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entitled 'Genetically Engineered Crops: Agencies Are Proposing Changes
to Improve Oversight, but Could Take Additional Steps to Enhance
Coordination and Monitoring' which was released on December 5, 2008.
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Report to the Committee on Agriculture, Nutrition, and Forestry, U.S.
Senate:
United States Government Accountability Office:
GAO:
November 2008:
Genetically Engineered Crops:
Agencies Are Proposing Changes to Improve Oversight, but Could Take
Additional Steps to Enhance Coordination and Monitoring:
GAO-09-60:
GAO Highlights:
Highlights of GAO-09-60, a report to the Committee on Agriculture,
Nutrition, and Forestry, U.S. Senate.
Why GAO Did This Study:
Genetically engineered (GE) crops—including crops engineered to resist
pests or tolerate herbicides—are widespread in the United States and
around the world. Taking direction from the 1986 Coordinated Framework
for Regulation of Biotechnology, the U.S. Department of Agriculture
(USDA), Environmental Protection Agency (EPA), and Food and Drug
Administration (FDA) regulate GE crops to ensure that they are safe.
The unauthorized mixing of some GE crops with non-GE crops has caused
controversy and financial harm. GAO examined (1) unauthorized releases
of GE crops, (2) coordination among the three agencies, and (3)
additional actions they have proposed to improve oversight. GAO
gathered data from agencies and stakeholders; used criteria from prior
GAO work to assess coordination; and reviewed agency proposals.
What GAO Found:
Unauthorized releases of GE crops into food, animal feed, or the
environment beyond farm fields have occurred, and it is likely that
such incidents will occur again. While there is no evidence that the
six known releases into the food or feed supply or into crops meant for
the food or feed supply affected human or animal health, some resulted
in lost trade opportunities. Moreover, the total number of unauthorized
releases into the environment is unknown. USDA and EPA have the
authority to inspect fields in which GE crops are tested, but crop
developers have detected most violations. USDA and EPA have taken
enforcement actions in response to violations, ranging from warning
letters to significant penalties. The agencies have used lessons
learned from unauthorized releases to make regulatory and policy
changes. For example, USDA increased inspections of field trial sites
for GE crops producing pharmaceutical compounds; EPA discontinued a
policy under which a GE crop containing a pesticidal agent could be
approved for animal feed, but not for food; and FDA established a
voluntary early food safety evaluation program for certain GE crops
intended for food use to help mitigate the impact should unauthorized
releases occur during field trials, although it has not made these
evaluations available to the public.
USDA, EPA, and FDA routinely coordinate their oversight and regulation
of GE crops in many respects, but could improve their efforts.
Specifically, USDA and FDA do not have a formal method for sharing
information that could enhance FDA’s voluntary early food safety review
for certain GE crops in the field trial stage and support USDA’s
oversight. Also, the three agencies do not have a coordinated program
for monitoring the use of marketed GE crops to determine whether the
spread of genetic traits is causing undesirable effects on the
environment, non-GE segments of agriculture, or food safety, as
recommended by the National Research Council and others.
USDA, EPA, and FDA have proposed regulatory changes intended to improve
their oversight of GE crops. In 2007, USDA assessed a wide array of
regulatory alternatives that could redefine, on the basis of risk,
which GE crops it regulates and how it will respond to unauthorized
releases. USDA’s fiscal year 2009 budget request also seeks funding for
a voluntary system to help GE crop developers employ best management
practices to reduce the risk of unauthorized releases. Furthermore, the
2008 Farm Bill required USDA to take actions on lessons learned from
its investigation of an unauthorized release of GE rice. EPA has
proposed several changes to its regulations for GE crops that produce
pesticides, including one change that would distinguish between
pesticidal agents produced in GE crops and those applied topically to
crops. In 2001, FDA proposed to require that GE food developers notify
the agency before marketing their products. However, as of July 2008,
FDA had not taken action to finalize the proposed rule, believing its
current approach calling for voluntary notice is sufficient.
What GAO Recommends:
GAO recommends that (1) FDA make public the results of its early food
safety assessments of GE crops; (2) USDA and FDA develop an agreement
to share information on GE crops with traits that, if released into the
food or feed supply, could cause health concerns; and (3) USDA, EPA,
and FDA develop a risk-based strategy for monitoring the widespread use
of marketed GE crops. FDA agreed with the first recommendation, and,
with USDA, agreed in part with the second. The agencies agreed in part
with the third recommendation. We stand by the recommendations.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-60]. For more
information, contact Lisa Shames at (202) 512-3841, or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Unauthorized Releases of GE Crops Have Caused Financial Losses, and the
Agencies Have Taken Steps to Reduce the Likelihood of Future Releases:
Routine Interagency Coordination of Programs Occurs, but Opportunities
Exist for Further Coordination among the Agencies:
Agencies Are Considering Regulatory Changes and Other Initiatives to
Improve Oversight and Further Limit the Impact of Potential
Unauthorized Releases:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Comments from the U.S. Department of Agriculture:
Appendix III: Comments from the Department of Health and Human Services
(FDA):
Appendix IV: U.S. Legal Framework for Regulation of GE Crops:
Appendix V: Summary Information on USDA Notifications and Permits for
Field Trials of GE Crops:
Appendix VI: Information on the Commercialization of GE Crops:
Appendix VII: Six Documented Incidents of Unauthorized Release of GE
Crops into the Food and Feed Supply:
Appendix VIII: GE Regulatory Issues and Alternatives Discussed in
USDA's DEIS and Proposed Rule:
Appendix IX: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Key Statutes Relevant to the Regulation of GE Plants:
Table 2: Summary of the Six Known Unauthorized Releases of Regulated GE
Crops into the Food and Feed Supply, 2000-2008:
Table 3: USDA Data on Incidents from January 2003 through August 2007:
Table 4: Key Legislation That Is Relevant to the Regulation of GE
Crops:
Table 5: GE Crops Granted Nonregulated Status by USDA and their
Marketing Status in the United States and Other Countries:
Table 6: GE Regulatory Issues and Alternatives Discussed in USDA's DEIS
and Proposed Rule:
Figures:
Figure 1: Use of Biotechnology to Create a Pest-Resistant Plant:
Figure 2: USDA Enforcement Actions, 2003 through 2007:
Figure 3: Annual Number of Notifications and Permits Approved by USDA,
1987 through 2007:
Figure 4: Number of Field Trials by the Genetic Characteristic Tested,
1987 through 2007:
Abbreviations:
APHIS: Animal and Plant Health Inspection Service:
BQMS: Biotechnology Quality Management System:
Bt: Bacillus thuringiensis:
DEIS: draft programmatic environmental impact statement:
EPA: Environmental Protection Agency:
FDA: Food and Drug Administration:
FFDCA: Federal Food, Drug, and Cosmetic Act:
FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act:
GE: genetic engineering:
IES: Investigative and Enforcement Services:
OECD: Organisation for Economic Cooperation and Development:
OSTP: Office of Science and Technology Policy:
PPA: Plant Protection Act:
PVCP: plant virus coat protein:
USDA: U.S. Department of Agriculture:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
November 5, 2008:
The Honorable Tom Harkin:
Chairman:
The Honorable Saxby Chambliss:
Ranking Member:
Committee on Agriculture, Nutrition, and Forestry:
United States Senate:
The genetic engineering of agricultural crops is seen as both promising
and controversial, with potentially significant implications for the
United States' and other countries' food security and economic well-
being, the environment, and international relations and trade.
Proponents cite the potential for enhanced crop yields; more
environmentally friendly food production; more nutritious foods; and
the increased use of plants to inexpensively produce pharmaceutical
compounds, such as human or veterinary drugs, or industrial compounds,
such as substances used in paper production or detergent manufacturing.
Opponents argue that not enough is known about the safety of
genetically engineered (GE) crops and food, and that they should be
more rigorously controlled than conventional alternatives. This debate
has been exacerbated by several well-publicized cases of unauthorized
release of GE crops into the food supply. For example, in August 2006,
the U.S. Department of Agriculture (USDA) announced that trace amounts
of a regulated variety of GE rice had been commingled with supplies of
conventional rice. This announcement led several U.S. trading partners
to refuse U.S. rice exports, potentially disrupting the $1.3 billion
U.S. rice export market and leading to financial losses for U.S.
farmers and exporters. Furthermore, there also is concern that genetic
traits could spread from crops into the environment with unintended
consequences for plants and animals. This debate may intensify in the
future as genetic modifications to crops become more complex, and as
pressures build to increase agricultural yields to meet the growing
demand for food and biofuel.
Currently, the United States accounts for about 50 percent of the GE
crops planted globally. In 2008, GE varieties accounted for about 80
percent of the corn, 92 percent of the soybeans, and 86 percent of the
cotton planted in the United States. In 2005, GE varieties accounted
for about 93 percent of the canola. To date, the most common
characteristics, or traits, engineered into these crops have been
resistance to insect pests and the ability to tolerate specific
herbicides. The global value of GE seeds sold in 2007 was estimated at
$6.9 billion. Food industry sources indicate that over 70 percent of
processed foods sold in the United States contain ingredients and oils
from GE crops. Increasingly, some countries--including Argentina,
Brazil, Canada, and India--have embraced GE crops and food to, among
other things, increase yields. Other countries--including many in the
European Union and some in Africa--have resisted GE crops and food,
citing safety and economic concerns.
Three federal agencies have primary responsibility for regulating GE
crops and food in the United States: USDA, the Environmental Protection
Agency (EPA), and the Food and Drug Administration (FDA). USDA is
responsible for assessing whether GE crops pose a risk as "plant pests"
that could directly or indirectly harm plants. To accomplish this, USDA
regulates the importation, interstate movement, and release of GE crops
into the environment, the latter of which could occur when a developer
tests the crop in a field trial. USDA may, upon finding a GE crop does
not pose a potential plant pest risk, grant a petition to extend
"nonregulated" status to the crop, meaning that it can be moved or
released without agency oversight. USDA also has the authority to
regulate GE plants as noxious weeds; a noxious weed is any plant or
plant product that can injure or cause damage to, among other things,
crops, livestock, interests of agriculture, public health, or the
environment. EPA is responsible for regulating all pesticides,
including those produced by plants that have been genetically modified
to protect themselves from insects, bacteria, and viruses. USDA and, to
a lesser extent, EPA exercise oversight of the thousands of field
trials in which developers have tested new varieties of GE plants since
1987. FDA has primary responsibility for ensuring the safety of most of
the nation's food supply and encourages companies to voluntarily submit
safety data on a new food or feed derived from GE crops before it is
marketed. The President's Office of Science and Technology Policy
(OSTP) published the final version of the Coordinated Framework for
Regulation of Biotechnology (Coordinated Framework) in 1986. This
document outlines the federal government's policy for ensuring the
safety of GE organisms, including relevant laws and definitions. It was
developed in response to concerns that products resulting from genetic
engineering might pose greater risks than those resulting from
traditional breeding techniques.
In this context, you asked us to examine (1) unauthorized releases of
GE crops into the food or feed supply, or the environment; (2) the
degree of coordination among the three key agencies that regulate GE
crops under the 1986 Coordinated Framework--USDA, EPA, and FDA; and (3)
additional actions these agencies have proposed to improve the
oversight of GE crops and reduce the potential for unauthorized
releases.
In conducting this work, we spoke with and reviewed documents provided
by officials at USDA, EPA, and FDA as well as OSTP, which is charged
with coordinating federal government policy on biotechnology. We also
reviewed scientific and technical studies and other literature and
spoke with officials in academia, private industry, and consumer
groups. We reviewed applicable laws and regulations as well as
available public comments on several agency-proposed GE regulations or
initiatives as of October 2008. In addition, we reviewed information on
all known unauthorized releases of GE crops into the food or feed
supply as of September 2008, and on potentially unauthorized releases
of GE crops into the environment for the period of January 2003 through
August 2007. We assessed the agencies' coordination efforts, using
criteria that we have developed in prior work on agency collaboration
and coordination.[Footnote 1] We did not assess the federal regulation
of GE animals. Furthermore, we did not assess U.S. efforts to reduce
barriers to international trade in GE agricultural commodities. A more
detailed description of our objectives, scope and methodology is
presented in appendix I. We conducted this performance audit from July
2007 to November 2008 in accordance with generally accepted government
auditing standards. These standards require that we plan and perform
our audit to obtain sufficient, appropriate evidence to provide a
reasonable basis for our findings and conclusions based on our audit
objectives. We believe that the evidence obtained provides this
reasonable basis.
Results in Brief:
Federal agencies have documented six unauthorized releases of GE crops
into the food and feed supply or into crops meant for the food or feed
supply and additional releases into the environment, as of September
2008, and the ease with which genetic material from crops can be spread
makes future releases likely. While the agencies maintain that there is
no evidence that any of the known releases have adversely affected
human or animal health or the environment, several releases resulted in
food recalls or lost trade opportunities that caused financial losses.
Moreover, the actual number of unauthorized releases is unknown.
Specifically, while USDA and EPA regulations subject crop developers to
periodic inspections by federal or state personnel to ensure that
developers have taken adequate measures to isolate regulated GE crops
from other crops, USDA does not have the resources to inspect all
sites, and EPA and the states have not made inspections a priority. In
most cases, crop developers have self-reported known unauthorized
releases and other violations of regulations. USDA and EPA have taken
enforcement actions--ranging from issuing warning letters to assessing
significant financial penalties--against GE crop developers who
violated regulations. USDA, EPA, and FDA have also taken steps in
response to these incidents to reduce the potential for future
unauthorized releases and to mitigate the impact of any releases. For
example, USDA has increased the frequency of inspections of field trial
sites for GE crops producing pharmaceutical and industrial compounds;
EPA has discontinued a policy under which a GE crop containing a
pesticidal agent could be approved for animal feed, but not for food;
and FDA has established a voluntary early food safety evaluation of GE
crops that might pose a new risk to help mitigate the impact of
unauthorized releases, although FDA has not yet fulfilled a commitment
to publish the results of those evaluations.
As called for by the Coordinated Framework and measured against other
established criteria, the three federal agencies routinely work
together to regulate GE crops. For example, the agencies have agreed on
their respective roles and responsibilities and developed mechanisms
for making policy decisions, sharing information, and responding to
incidents. However, the agencies could enhance their coordination by
leveraging resources and developing mechanisms to monitor and evaluate
results. For example, USDA and FDA do not have a formal method for
sharing information that could enhance FDA's voluntary early food
safety evaluation of certain GE crops in the field trial stage and
USDA's oversight of those field trials. Sharing such information could
better leverage resources to address food safety issues for GE crops at
the field trial stage. In addition, USDA, EPA, and FDA do not have a
coordinated program for monitoring and evaluating the use of marketed
GE crops to determine whether they are causing (1) undesirable effects
to the environment or economic harm to non-GE segments of agriculture
through the unintentional spread of GE traits or (2) food safety
concerns, such as the unintentional introduction of pharmaceutical or
industrial compounds into the food supply. Several organizations, such
as the National Research Council, have made such recommendations
regarding the monitoring of GE crops.
USDA, EPA, and FDA have proposed several regulatory changes intended to
improve the oversight of GE crops and reduce the potential for
unauthorized release. For example, in July 2007, USDA released a draft
programmatic environmental impact statement (DEIS) that assessed
proposals to modify many aspects of how the agency regulates GE crops,
such as how it will respond to the unauthorized release of low levels
of GE crops and how it will address the food safety risks posed by GE
crops that produce pharmaceutical or industrial compounds when setting
requirements for field trials. In October 2008, USDA released for
public comment its proposed amendments to those regulations. In
addition, USDA's fiscal year 2009 budget request seeks funding to
establish a voluntary system to encourage GE crop developers to employ
best management practices for field trials and the handling of
regulated materials, including third-party audits of their field trial
plans and records. The Food, Conservation, and Energy Act of 2008 (2008
Farm Bill) directs USDA to consider regulatory and procedural changes
based on the agency's Lessons Learned and Revisions Under Consideration
for APHIS' Biotechnology Framework, a document resulting from lessons
learned from its investigation of the unauthorized release of GE rice
into the food supply in 2006, as well as from its years of regulatory
experience, and to take action to, among other things, enhance the
availability of genetic samples from developers and the quality and
completeness of records by developers. For its part, EPA is working on
three proposed changes to regulations, including one that would make a
distinction between pesticidal agents produced in GE crops and
pesticides made from chemicals that are applied topically to crops,
noting that currently approved GE-based pesticides are less toxic and,
therefore, generally present less risk. FDA proposed in 2001 to
require--rather than to encourage, as it does now--developers of GE
food products to consult with the agency about the safety of the food
before it is marketed. However, as of July 2008, FDA had not taken
action to finalize the proposed rule. FDA officials told us that such a
rule may no longer be needed because the voluntary consultation process
is working well and fully protects the public health.
To ensure that the federal government addresses emerging risks
associated with new developments in GE crops, we are recommending that
FDA post on its Web site the results of its early food safety
evaluations, and that USDA and FDA develop a formal agreement to share
information concerning GE crops with novel genetic traits that could
cause, or are likely to cause, health concerns if unintentionally
released into the food or feed supply. We are also recommending that
USDA, EPA, and FDA develop a coordinated strategy for monitoring the
marketed use of GE crops for unintended consequences to the
environment, non-GE segments of agriculture, or food safety.
In commenting on a draft of this report, USDA, EPA, and FDA generally
agreed with the report's findings. On the first recommendation, FDA
said it intends to make every effort to fulfill its commitment to post
to its Web site the results of completed and future early food safety
evaluations. However, FDA also said that activities of greater public
health priority have been the focus of its limited resources.
Nevertheless, we believe that posting the results of these evaluations
would be a low-cost way to increase public transparency and mitigate
the impact of unintended releases of GE crops. Regarding the second
recommendation, USDA and FDA agreed, in part, saying that they would
explore the development of a formal agreement for sharing information
on GE crops with novel genetic traits. However, they also said that
they should focus their resources on issues that present or are likely
to present public health concerns, rather than perceived concerns. We
modified this recommendation to remove the reference to "perceived
health concerns" and instead emphasize that the agreement would cover
GE crops that present or are likely to present public health concerns.
Concerning the third recommendation, USDA, EPA, and FDA agreed, in
part, to the development of a coordinated strategy to do risk-based
monitoring of marketed GE crops for unintended consequences. However,
USDA emphasized that its current regulations limit it to monitoring
only regulated crops that pose a potential plant pest risk; EPA stated
that GE crops that produce pesticides do not require any further post-
market monitoring; and FDA said post-market monitoring of food and feed
derived from GE crops is not necessary and random sampling to detect GE
crops producing pharmaceutical or industrial substances in food and
feed would present significant technical challenges and greatly affect
resources. Nevertheless, the agencies agreed to enter into discussions
to develop a coordinated strategy should such monitoring be necessary
in the future. Given that in the United States (1) GE crop varieties
are grown extensively, (2) most processed foods contain ingredients
from GE crops, (3) it is inherently difficult to prevent the spread of
plant genetic material in the environment, (4) there may be an
increasing use of GE crops to produce an even wider array of
pharmaceutical and industrial compounds in the future, and (5) genetic
modifications are becoming increasingly complex in response to
pressures to increase yields for food and biofuel, we continue to
believe the agencies should develop a coordinated strategy for risk-
based monitoring of marketed GE crops.
USDA's and FDA's comments are presented in appendixes II and III,
respectively. EPA provided its comments orally. EPA and FDA also
provided technical comments that we have incorporated as appropriate.
Background:
Genetic engineering refers to the technology of modifying the genetic
makeup of crops, animals, or microorganisms by introducing genes for
specific traits. For centuries, people have crossbred related plants or
animal species to develop useful new varieties or hybrids with
desirable traits, such as better taste or increased productivity.
Traditional crossbreeding, however, can be very time-consuming because
it may require breeding several generations to obtain a desired trait
and breed out numerous unwanted characteristics. Genetic engineering
techniques allow for faster development of new crop or livestock
varieties, since the genes for a given trait can be readily
incorporated into a plant or animal species to produce a new variety
incorporating that specific trait. In addition, genetic engineering
increases the range of traits available for developing new varieties by
allowing genes from totally unrelated species to be incorporated into a
particular crop or animal variety.
Seed developers have experimented with engineering a wide variety of
traits into plants, including insect resistance; herbicide tolerance;
resistance to viruses, bacteria, and fungi; enhanced product quality,
such as increased oil content, delayed ripening, and altered color; and
other properties, such as increased tolerance to drought or cold. For
example, as shown in figure 1, scientists produced insect-resistant
plants by identifying a gene responsible for insect resistance in an
organism, isolating and copying the gene, and then inserting the gene
into the target plant's DNA.
Figure 1: Use of Biotechnology to Create a Pest-Resistant Plant:
[Refer to PDF for image]
This figure illustrates the use of biotechnology to create a pest-
resistant plant, as follows:
* The microorganism Bacillus thuringiensis (Bt) produces an
insecticidal substance.
* Bt gene is inserted into corn (maize) DNA.
* The resulting corn variety (Bt corn) produces its own insecticide,
reducing the need for farmers to spray pesticides.
Sources: GAO and Art Explosion (clip art).
[End of figure]
In 1986, OSTP published the Coordinated Framework, which outlined the
regulatory approach; relevant laws; and regulations for, and a
definition of, GE organisms. This document states that existing
statutes provide a basic network of agency jurisdiction over genetic
engineering both for research and products. The statutes most relevant
to the regulation of GE crops are shown in table 1, with additional
details provided in appendix IV. In 1992, OSTP elaborated on the
Coordinated Framework with a policy announcement that (1) called for
the oversight of GE organisms only when there is evidence of
"unreasonable" risk, that is, when the reduction in risk obtained by
oversight is greater than the cost of oversight, and (2) expected
federal agencies to focus on the characteristics and risks of
biotechnology products, not on the process by which these products are
created.
Table 1: Key Statutes Relevant to the Regulation of GE Plants:
Statute: Plant Protection Act[A] (PPA);
Relevance to the regulation of GE crops: Authorizes the Secretary of
Agriculture to regulate the importation or movement in interstate
commerce of plants and articles, including GE crops, that might
introduce or disseminate a plant pest or noxious weed.
Statute: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA);
Relevance to the regulation of GE crops: Authorizes the EPA
Administrator to register pesticides and regulate the distribution and
use of nonregistered pesticides, which would include those genetically
engineered into plants.
Statute: Federal Food, Drug, and Cosmetic Act (FFDCA);
Relevance to the regulation of GE crops: Authorizes the Secretary of
Health and Human Services (delegated to FDA) to regulate food, animal
feed, additives, and human and animal drugs, which would include those
derived from biotechnology such as GE crops; In addition, authorizes
the Administrator of EPA to establish tolerances or tolerance
exemptions for pesticidal chemical residues.
Statute: National Environmental Policy Act of 1969;
Relevance to the regulation of GE crops: Requires all federal agencies
to consider the likely environmental effects of actions they are
proposing, and if those actions would significantly affect the
environment, provide an environmental impact statement. Such statements
could be required for actions related to the regulation of GE crops.
Source: GAO.
[A] In 2000, the Plant Protection Act incorporated many authorities of
the Federal Plant Pest Act, the Plant Quarantine Act, and the Federal
Noxious Weed Act of 1974 and repealed all but a few provisions of those
acts.
[End of table]
Responsibility for implementing the Coordinated Framework fell
primarily to three agencies--USDA, EPA, and FDA--with USDA designated
as the lead agency for plants and animals. Each agency has specific
requirements for certain activities with GE crops, and not all three
agencies are necessarily involved in overseeing each activity or use of
a GE crop. The applicability of these requirements to GE crops depends
upon several factors, including the type of trait engineered into the
plant and the proposed use of the crop. Specific responsibilities of
the agencies are described in the following text.
USDA Oversees the Movement and Environmental Releases of Regulated GE
Crops:
USDA regulations require persons seeking to import, move interstate, or
release into the environment GE crops to first submit a notification to
the agency or obtain a permit, depending on the risk that the GE crop
poses, with notification being the more administratively streamlined
option:
* Notification: USDA regulations provide that GE crops may be released
into the environment or moved under a notification, rather than with a
permit, if they meet the following six criteria.
1. The GE crop species is not listed in regulation as a noxious weed or
considered by the Administrator of USDA's Animal and Plant Health
Inspection Service to be a weed for the area of release.
2. The introduced genetic material is "stably integrated" in the crop's
genome.
3. The function of the introduced genetic material is known and does
not result in plant disease.
4. The introduced genetic material does not cause the production of an
infectious entity, produce a substance that is likely to be toxic to
nontarget organisms, or produce a product intended for pharmaceutical
or industrial use.
5. The introduced genetic sequences do not pose a significant risk of
the creation of a new plant virus.
6. The crop has not been modified to contain certain genetic material
from animal or human pathogens.
USDA regulations also require that activities conducted under a
notification meet certain performance standards. Namely, regulated GE
crops must be handled in such a way that they do not persist in the
environment or get mixed with nonregulated plant materials. A general
technique for avoiding mixing is to isolate the GE crops from non-GE
crops, and USDA has described in guidance documents a number of steps
that developers may take, such as bagging or netting the plants to
contain the seeds, planting border rows, or using sterile male
varieties.
* Permit: The USDA permit process is for those GE crops that cannot be
introduced under notification, such as plants engineered to produce
pharmaceutical or industrial compounds or modified with genetic
material that causes the production of an infectious entity or toxic
substance. Permits spell out specific requirements for conducting the
activity, with the permit conditions for GE crops that produce
pharmaceutical or industrial compounds typically being the most
restrictive. For example, permit conditions for these types of GE crops
require that the fallow zones around field trial sites be larger than
for other types of crops, that farmers use dedicated machinery
(harvesters or planters) and storage facilities, and that the permit
holder implement a training program for its personnel.
Permits or notifications are also required for the interstate movement
or importation of regulated GE crops. For example, the requirements
relevant to these permits address such matters as the points of origin
and destination, packaging, and record keeping.
From fiscal years 1987 through 2007, USDA issued almost 19,000
notifications and almost 4,300 permits for environmental releases,
importation, and interstate movement. Over 13,000 of the notifications
and permits were for releases into the environment, also known as field
trials.[Footnote 2] A single permit or notification for a field trial
may cover more than one location at which a GE crop can be tested. (See
app. V for details on the yearly rate at which USDA has issued permits
and acknowledged notifications for field trials and on the types of
genetic characteristics those trials covered.)
USDA regulations also allow for persons, including GE crop developers,
to petition the agency to deregulate a GE crop. If USDA deregulates the
crop, it is no longer subject to regulatory control under the Plant
Protection Act, unless USDA finds it to be a plant pest or noxious weed
on the basis of new data or analysis. Petitioning USDA is the typical
route to commercialization, since it allows planting with less
restrictive conditions than those imposed by a permit or the
notification process. However, according to USDA officials, a GE crop
developer could market a product that is still regulated. As of July
2008, USDA had received 113 petitions for deregulation and approved 73.
(See app. VI for more details on deregulated and marketed GE crops.)
EPA Regulates Pesticides Produced in GE Crops:
EPA is responsible for regulating the genetic materials engineered into
a crop to produce pesticides that ward off insects, bacteria, and
viruses, as well as the pesticide that the crop ultimately produces
(known as a "plant-incorporated protectant," but referred to in this
report as a "GE pesticide"). As with conventional chemical or
biological pesticides, EPA regulates the sale, distribution, and use of
GE pesticides, and producers must register them before they are put
into commercial use. Since 1995, EPA has registered 29 GE pesticides
engineered into 3 crops--corn, cotton, and potatoes--5 of which have
since been voluntarily canceled. (See app. VI for more details about
EPA's process for registering GE pesticides.)
EPA requires persons seeking to conduct field trials of GE crops
containing pesticides on more than 10 cumulative acres to apply for an
experimental use permit. These crops generally have shown promise in
previous small-scale field trials (less than 10 cumulative acres)
regulated by USDA and are potential candidates for future
commercialization. To receive a permit, applicants must submit data to
EPA on the descriptions and specific results of any appropriate prior
testing of the product conducted by the applicants to determine
toxicity, effects on the environment, and other matters associated with
the GE pesticide. According to EPA, it requires that applicants
demonstrate that regulated genetic material will not spread into other
plants. In the absence of such a showing, EPA will impose containment
measures which may be similar to those that USDA requires to address
potential environmental risks. If it can be reasonably expected that
the field trial will result in pesticide residues in food or feed, the
applicant must submit evidence that a tolerance or tolerance exemption
has been established or submit a petition for the establishment of a
tolerance or tolerance exemption, or certify that the food or feed is
disposed of in a manner that ensures it will not endanger man or the
environment.
Although EPA establishes tolerances, FDA, not EPA, is responsible for
enforcing tolerances for pesticide residues on foods derived from GE
crops. If EPA determines that there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide residue, it
may grant an exemption from the requirement for a tolerance. FDA may
take enforcement actions if residue of a GE pesticide enters into the
food supply without a tolerance or exemption from tolerance. From
fiscal years 1997 through 2007, EPA issued 65 experimental use permits
for field trials of GE pesticides, or about 6 such permits per year. As
of June 1, 2008, there were 8 active permits for GE pesticides,
covering about 26,000 acres. According to EPA, it generally considers
small-scale field trials to have adequate containment measures if they
are conducted under USDA authorization and are in compliance with USDA
requirements and meet EPA's requirement that no pesticide residues can
be in the food or feed supply unless there is a tolerance or tolerance
exemption in place.
FDA Encourages Developers to Consult on Food Safety Issues before
Marketing GE Crops, and Regulates GE Pharmaceutical Products:
FDA is responsible for ensuring the safety of most of the food supply,
with the exception of meat, poultry, and egg products, which are under
USDA's authority. FDA established its basic policy regarding the review
of GE foods in its 1992 Statement of Policy: Foods Derived from New
Plant Varieties, which explained that substances introduced into food
or feed by way of breeding were potential food additives if they were
not generally recognized as safe or if they were pesticides, and
described the kinds of assessments FDA expected companies to perform to
assure themselves that foods and feeds from new plant varieties were as
safe as comparable foods and feeds already on the market, and otherwise
did not raise regulatory concerns. In 1995, FDA established its
voluntary consultation process, through which companies developing
foods and feeds from GE plants voluntarily notify the agency and submit
a safety assessment report containing a summary of test data and other
information on the foods before they are marketed. The company
evaluates, for example, whether the level of allergens, toxins,
nutrients, and antinutrients--compounds that inhibit the absorption of
nutrients--in the GE food is comparable to the level of these
substances in the food's conventional counterpart, and whether the GE
food contains any new allergens or toxins. FDA assists the company with
questions related to the regulatory status of the food. If FDA has no
further questions about the safety of the food or feed, it provides the
company with a letter to that effect. Although the consultation process
is voluntary, it is FDA's experience that companies do not commercially
market their GE crops until they have received this letter. As of July
2008, FDA had completed 72 voluntary consultations on GE crops intended
for use in animal feed, human food, or both. FDA does not track which
of these GE crops have been marketed; industry data indicate that many
have been, but that some are no longer commercially available. (See
app. VI for more details about GE crops that developers have marketed.)
For plants engineered for a nonfood use, such as those that produce a
pharmaceutical compound, FDA subjects the pharmaceutical product to the
drug or biologic review and approval process. In 2002, in collaboration
with USDA, FDA published draft guidance to the biotechnology industry
that outlined some of the steps industry should take to ensure that
regulated products do not become mixed with the food or feed supply and
manufacturing information that should be submitted to FDA with
applications for marketing approval.
Unauthorized Releases of GE Crops Have Caused Financial Losses, and the
Agencies Have Taken Steps to Reduce the Likelihood of Future Releases:
Federal agencies have documented the unauthorized releases of regulated
GE crops into the food supply and the environment. While none of these
releases are known to have affected human or animal health or the
environment, some releases into the food supply had substantial
financial consequences. Specifically, there have been six known
releases of GE crops into the food or feed supply or into crops meant
for the food or feed supply; with the first occurring in 2000. While
these releases have not harmed human or animal health, several had
significant financial consequences, including product recalls and
destruction and lost trade opportunities. USDA data indicate that there
have been more unauthorized releases of regulated crops into the
environment, but the agency says that they have not caused
environmental harm. USDA and EPA have taken enforcement actions in
response to violations, including several large financial penalties.
All three agencies have taken steps in response to known unauthorized
releases to reduce the potential for future unauthorized releases or to
mitigate their impact.
Known Unauthorized Releases of GE Crops Apparently Have Not Caused
Health Effects, but Several Caused Financial Losses:
There have been six known incidents of the unauthorized release of
regulated GE crops into the food supply or into crops meant for the
food supply--four involving GE varieties of corn and the remaining two
involving a GE variety of rice. (See table 2.) These incidents
apparently have not caused health effects, but several led to financial
losses for farmers and exporters. While the specific causes of
unauthorized releases vary by incident, from cross-pollination of
regulated and conventional crops to the mislabeling of bags of seeds,
they highlight the challenges of containing regulated GE crops given
the porous nature of biological systems and the potential for human
error. (See app. VII for a detailed description of each of these
incidents.) According to USDA, large-scale annual field testing of GE
crops occasionally results in materials from these trials being
detected at low levels in commercial commodities and seeds. Most
officials we asked, including representatives from the biotechnology
industry, agricultural commodity growers, and consumer advocacy
organizations, also told us that future unauthorized releases of low
levels of regulated GE material are likely to occur.
Table 2: Summary of the Six Known Unauthorized Releases of Regulated GE
Crops into the Food and Feed Supply, 2000-2008:
Year: 2000;
Product: StarLink;
Crop: Corn;
Trait: Insect resistance and herbicide tolerance;
Cause: Cross-pollination, commingling of corn after harvest;
Detection: Third-party testing.
Year: 2002;
Product: Prodigene;
Crop: Corn;
Trait: Pharmaceutical protein;
Cause: Cross-pollination and uncontrolled volunteers[A];
Detection: USDA inspection.
Year: 2004;
Product: Syngenta Bt10;
Crop: Corn;
Trait: Insect resistance;
Cause: Misidentified seed;
Detection: Third-party testing.
Year: 2006;
Product: Liberty Link Rice 601;
Crop: Rice;
Trait: Herbicide tolerance;
Cause: Not determined;
Detection: Third-party testing.
Year: 2006;
Product: Liberty Link Rice 604;
Crop: Rice;
Trait: Herbicide tolerance;
Cause: Not determined;
Detection: Third-party testing.
Year: 2008;
Product: Event 32;
Crop: Corn;
Trait: Insect resistance;
Cause: Under investigation;
Detection: Developer testing.
Source: GAO analysis of USDA and EPA data.
[A] "Uncontrolled volunteers" refers to plants from a previous season's
field trial that grow on their own without being deliberately planted.
[End of table]
The regulated materials in these six incidents were detected at
different points in the food and feed supply. For example, in the
StarLink corn incident--a GE corn containing a pesticidal protein that
was approved only for animal feed and not for human food--trace amounts
of the pesticidal protein were detected in consumer products, such as
taco shells and corn bread. The presence of the pesticidal protein in
human food rendered it adulterated. Therefore, FDA requested food
processors to recall potentially affected food products. In the
Prodigene corn incident, USDA discovered that the regulated crop had
been mistakenly harvested and commingled with soybeans in a grain silo.
USDA ordered the soybeans and GE corn destroyed before they were sold
commercially.
With the exception of Prodigene corn, the regulated material in all of
the incidents involved traits of herbicide tolerance and insect
resistance familiar to federal regulators. In addition, the regulated
materials found in Syngenta Bt10, Liberty Link Rice 601 (LLRICE 601),
Liberty Link Rice 604 (LLRICE 604), and Event 32, were very similar to
GE material that had already been reviewed by EPA, FDA, or both, and
deregulated by USDA. Shortly after each of these four incidents, EPA,
FDA, or both, issued statements attesting to the safety of the low-
level presence of the regulated GE crops in the food and feed supply.
While USDA, EPA, and FDA have determined that none of these six
incidents of unauthorized release harmed human or animal health, some
cases led to financial losses, particularly from lost sales to
countries that would not accept crops containing the regulated GE
varieties. For example, in response to the detection of regulated GE
rice in commercial rice supplies in the United States in 2006, several
of the leading importers of U.S. rice either banned the import of
certain varieties of rice imports or imposed new testing requirements
on rice traders. However, it is difficult to quantify the financial
losses resulting from these unauthorized releases because many factors
may determine the final sale price of commodity agriculture. Of the few
estimates available, one by a group of economists estimated that the
StarLink incident resulted in $26 million to $288 million in lost
revenue for producers in market year 2000/2001. (According to USDA,
U.S. cash receipts for corn totaled about $15.2 billion in 2000.)
Similarly, a separate study by university economists estimated that the
presence of StarLink in the food supply in 2000 caused a 6.8 percent
drop in the price of corn, lasting for 1 year. More recently, an
environmental advocacy group estimated that the worldwide costs
resulting from the LLRICE incidents, including the costs associated
with the loss of export markets, seed testing, elevator cleaning, and
food recalls in countries where the variety of rice had not been
approved, ranged from $741 million to $1.285 billion.
USDA Says That Unauthorized Releases of GE Crops Have Not Caused
Environmental Harm:
In addition to known unauthorized releases to the food supply, USDA
data indicate there have been other potentially unauthorized releases
of GE crops into the environment. However, USDA has concluded that
these releases have not caused harm. Most of the reports of such
incidents were self-reported by the developers, rather than identified
through USDA inspections. In 2007, USDA analyzed its record of over 700
violations or potential violations that occurred from January 2003
through August 2007 and found 98 that indicated a possible release into
the environment, as shown in table 3.
Table 3: USDA Data on Incidents from January 2003 through August 2007:
Total number of permits and notifications: 6,983;
Number of violations or potential violations: 712;
USDA categories of violations that could indicate a release to the
environment: Persistence in the environment[B];
Number of violations or potential violations identified by USDA[A]: 7.
USDA categories of violations that could indicate a release to the
environment: Production and/or persistence of progeny (offspring);
Number of violations or potential violations identified by USDA[A]: 4.
USDA categories of violations that could indicate a release to the
environment: Animal-related release, incursion, destruction, or
consumption;
Number of violations or potential violations identified by USDA[A]: 33.
USDA categories of violations that could indicate a release to the
environment: Weather-related release, incursion, or destruction;
Number of violations or potential violations identified by USDA[A]: 17.
USDA categories of violations that could indicate a release to the
environment: Movement of propagules into the environment[C];
Number of violations or potential violations identified by USDA[A]: 16.
USDA categories of violations that could indicate a release to the
environment: Isolation distance or other flower control insufficiency;
Number of violations or potential violations identified by USDA[A]: 21.
Source: USDA.
[A] An incident may involve more than one violation or potential
violation.
[B] A GE crop that is persistent in the environment is one that
produces a sustained population in agricultural or nonagricultural
habitats without human intervention.
[C] Propagules are any part of a plant that can be detached from the
organism and propagated in order for it to grow into a new plant.
[End of table]
A concern associated with the release of a GE crop into the environment
is that its pollen containing its genetic characteristics may spread to
wild relatives. This is known as "gene flow." There is the potential
for the traits of insect resistance or herbicide tolerance to transfer
to weedy relatives of a crop, which could give the weeds a competitive
advantage or require a different herbicide for their control. The turf
grass known as "creeping bentgrass" is an example of this concern. The
Scotts Company has tested herbicide-resistant creeping bentgrass in the
hopes that it can be marketed for use on golf courses and lawns. In
2003, several environmental organizations and individuals filed suit
against the Secretary of Agriculture and other officials for, among
other things, permitting field tests of GE creeping bentgrass without
adequately determining whether the crop was a plant pest that could
spread to wild relatives or preparing an environmental impact statement
or environmental assessment pursuant to the National Environmental
Policy Act. Evidence presented in the case showed that the GE bentgrass
at the field test site had pollinated wild relatives. The court found
in February 2007 that there was no evidence that USDA considered
whether the permitted field tests had the potential to significantly
affect the environment when it decided that an environmental impact
statement or assessment was not necessary. The court held that USDA
could not process future permits without first considering whether the
field tests involve either new species or organisms or novel
modifications that raise new issues and, if either one exists, whether
the field tests likely would significantly affect the quality of the
human environment.
Agency Inspections Have Led to Some Enforcement Actions and Penalties:
USDA and EPA have the authority to conduct inspections of field trials
and other activities, and the agencies do so under their respective
regulations to help ensure compliance. USDA does not inspect all field
trial sites where GE crops are tested; instead, it uses a risk-based
approach to select sites for inspection. In response to violations,
USDA has taken enforcement actions, such as issuing enforcement letters
and assessing financial penalties. EPA, on the other hand, has
delegated primary enforcement authority--including inspection
responsibilities--to the states, but, according to EPA, neither the
agency nor the states have made these inspections a priority. In
response to violations, EPA has assessed several large financial
penalties, but otherwise has taken few enforcement actions. However,
USDA, EPA, and FDA have taken other actions in response to incidents of
the unauthorized release of GE crops to reduce the likelihood of future
releases or minimize their impact.
USDA Follows a Risk-Based Approach to Inspect Field Trial Sites:
USDA policy is to use a risk-based approach to selecting which field
trials covered by permits and notifications it will inspect. The
agency's most stringent policy applies to permits for field trials of
GE crops engineered to produce pharmaceutical or industrial compounds.
For those GE crops, USDA's policy calls for up to 7 inspections of
permitted field trials, both during and after the growing season. For
permits other than those for pharmaceutical or industrial compounds,
USDA's policy is to inspect every permit at least once in each state in
which a field trial is done. For example, if a permit allows for 15
field trial sites to be planted in 7 states, at least 1 inspection will
be done in each of the 7 states. According to USDA officials in charge
of the inspection program, the agency has met the inspection goals for
permitted field trials in recent years.
USDA policy does not call for inspecting all field trials done under a
less stringent notification. For fiscal years 2005 through 2007, USDA
selected for inspection about one-third of the field trials conducted
under the notification procedure on the basis of the developer's past
compliance record, the size of the field trial, the number of field
trial sites covered by the notification, and the type of crop being
tested, among other factors. A developer may conduct notification field
trials at many sites, but USDA does not necessarily inspect all of
those sites.
During inspections, USDA officials check records, make visual or
photographic observations, and conduct interviews to determine
regulatory compliance, including whether regulated material might have
been inadvertently released. However, these officials told us that they
do not have the resources to develop methods to conduct genetic testing
of the area surrounding a field test site as part of routine inspection
to determine with certainty whether regulated genetic material has
escaped the control of the biotechnology developer. Instead, USDA
relies on biotechnology developers to voluntarily provide them with the
genetic testing methodology and representative samples necessary to
detect regulated articles when USDA has reason to believe they may have
been released from a site. According to USDA officials, to date,
developers have been cooperative when asked to provide a testing
methodology and representative samples, although doing so is not a
requirement of the regulation.
Although USDA's inspection program has detected some violations of
regulations, it generally has found a high rate of compliance. Over the
3-year period from fiscal years 2005 through 2007, USDA inspected field
trials conducted under 489 permits and found that 18 (about 4 percent)
were out of compliance. USDA also found high compliance levels at field
trials operated under a notification; it completed 754 inspections over
the same period and found 17 instances of noncompliance (about 2
percent). Holders of USDA permits and notifications are required to
self-report, and most incidents have been identified by self-report,
rather than by inspection.
USDA Has Taken Enforcement Actions in Response to Violations and Has
Assessed Financial Penalties:
From calendar years 2003 through 2007, USDA's typical enforcement
action in response to regulatory violations generally was to issue an
order requiring the developer to take corrective action; in a small
number of other cases, USDA also obtained a civil monetary penalty from
the developers. USDA handled 320 incidents representing violations or
potential violations reported during this period. These incidents
included those self-reported by the developer and those detected by
USDA inspections. USDA resolved more than half of the incidents with an
acknowledgment letter or notice indicating that the developer had
returned to compliance or that the alleged incident was not, in fact, a
violation. The remaining incidents led to guidance letters or notices
of noncompliance, warning letters, or referrals to USDA's Investigative
and Enforcement Services (IES) (see figure 2).[Footnote 3]
Figure 2: USDA Enforcement Actions, 2003 through 2007:
[Refer to PDF for image]
This figure is a pie-chart depicting the following data:
USDA Enforcement Actions, 2003 through 2007:
Acknowledgment letter or notice of compliance: 54%;
Guidance letter or notice of compliance: 36%;
Referred to USDA’s IES: 5%;
Warning letter: 5%.
Source: GAO analysis of USDA data.
Note: Starting in 2005, guidance letters were changed to notices of
noncompliance.
[End of figure]
According to USDA officials, the agency refers serious incidents to
IES, and only incidents that have been referred to IES have resulted in
fines. We reviewed case files associated with the 17 referrals to IES.
Over half were initiated in 2005 to address nationwide noncompliance by
the Scotts Company in its development of GE creeping bentgrass. Those
violations included allowing GE grasses to form pollen that might have
pollinated plants outside of the field trial site, exceeding the
allowable acreage in a field trial, missing records for particular
field trial sites, allowing unauthorized movement of regulated GE grass
to locations outside of the field trial site, and lacking adequate
borders around field trial sites. In 2007, the company entered into a
consent decision with USDA and agreed to conduct three compliance
workshops and pay a $500,000 fine, which is the maximum allowable under
the statute.
Also among the referrals to IES was the 2004 Syngenta Bt10 corn
incident, for which USDA levied a $375,000 fine. Seven other incidents
that IES investigated in 2005 through 2007 resulted in financial
penalties ranging from $2,500 to $40,000. The seven violations included
failure to list a field trial site for a drought-resistant corn in its
permit; report that a storm blew regulated bentgrass outside of the
field trial site; and maintain the identity of regulated eucalyptus
trees being grown in a field trial. In four of these seven incidents,
the violator self-reported the incident.
EPA Has Delegated Its Inspection Responsibilities to the States:
EPA has delegated its primary enforcement authority, including
responsibility for most inspections of field trials conducted under
experimental use permits, to state agencies. However, according to EPA
officials, neither EPA nor the states consider monitoring field trial
permits for GE pesticides a high priority, partly because all of the GE
pesticides currently being grown in field trials have already been
evaluated for food, feed, and environmental risks and received a
tolerance or a tolerance exemption, indicating they are relatively low
risk.[Footnote 4] EPA does not collect information on how many
experimental use permits the states inspected. Furthermore, EPA does
not collect detailed information on the results of inspections. EPA can
initiate its own investigation when there is reason to believe that an
applicant is not meeting permit requirements. EPA officials told us
that they exercised this option for two field trials conducted by two
companies in Hawaii. In those instances, EPA targeted these field
trials for inspection because the permit holders did not have a
tolerance for the GE pesticide they were testing. EPA inspectors found
permit violations that could have resulted in the unauthorized release
of a GE pesticide. EPA officials said that, following these incidents,
the agency stopped issuing experimental use permits for field trials of
GE pesticides that do not have a tolerance or an exemption from
tolerance.
EPA Has Assessed Several Large Financial Penalties, but Has Taken Few
Other Enforcement Actions Related to GE Pesticides:
EPA has assessed several large financial penalties since it began to
regulate GE pesticides in 1986. Otherwise, however, the agency has
taken few enforcement actions. As of August 2008, EPA had issued
financial penalties on four occasions for violations of pesticide laws
and regulations involving GE pesticides, ranging from $8,800 to $1.5
million. Two of these occasions were related to violations of field
trial permit conditions in 2002. During the inspections in Hawaii of
field trials of GE pesticides being grown without a pesticide
tolerance, EPA inspectors found that one permit holder had planted
experimental corn in an unapproved location, and that another permit
holder did not have an appropriate buffer surrounding the field trial.
The permit holders were fined $9,900 and $8,800, respectively. In
addition, as part of its settlement, EPA required the first company to
perform tests to confirm that the experimental gene grown in the field
trial had not been transferred to adjacent fields. In 2003, EPA imposed
an additional $72,000 penalty on that company for failing to
immediately report to the agency the results of an initial test that
suggested that an inadvertent release of an unregistered pesticide had
occurred. Subsequent testing conducted by the company revealed that the
initial test had been incorrect, but EPA still fined the company for
failing to report the initial test results. On the remaining two
occasions, EPA issued fines of $165,200 in 1996 and $1.5 million in
2006 in response to separate incidents of the unauthorized sale and
distribution of a registered pesticide. The latter fine related to the
unauthorized release of Bt10 corn, as we have previously discussed.
Other enforcement options available to EPA include calling for the
destruction of products, as it did with Bt10 corn, or stopping the sale
of a product, as it did in the case of Event 32 corn.
Agencies Have Taken Actions in Response to Incidents of Unauthorized
Release to Reduce Their Likelihood or Minimize Their Impact:
In response to incidents of unauthorized release, USDA, EPA, and FDA
have taken several actions to either reduce the likelihood that
regulated crops would be unintentionally released into the food supply
or the environment or to minimize the impact of such occurrences. In
some cases, these actions were a response to specific incidents. For
example, the StarLink corn incident led to two significant policy
changes in the way that EPA regulates GE pesticides. First, EPA decided
to stop issuing split registrations--in which a product is approved for
animal feed but not for human consumption. StarLink had been the first-
-and the only--GE pesticide to receive a split registration. Second,
EPA began requiring developers of GE pesticides receiving a tolerance
or an exemption from tolerance to develop a quick-detection method for
the modified gene and provide it to EPA as part of the product's
registration. In addition, in March 2003, not long after the Prodigene
incident, USDA published a request for comments in the Federal Register
that included a description of more stringent permit conditions for
environmental releases of plants that produce pharmaceutical and
industrial compounds. USDA also announced that it would increase the
number of USDA field trial site inspections, stating that a field test
may have five inspections during the growing season and two additional
inspections post-harvest to look for volunteer plants. In addition,
USDA would restrict what can be grown on a test site and fallow zone in
the next growing season.
Other actions have been a response to releases in general. In an August
2002 Federal Register notice, OSTP articulated three principles
regarding field trials of GE crops: (1) the level of confinement under
which field tests are conducted should be consistent with the risks
posed; (2) if the risk is unacceptable or unknown, field trial
confinement requirements should be rigorous to prevent unauthorized
releases, and the occurrence of any genes and gene products from those
field tests in commercial seed, commodities, and processed food and
feed would be prohibited; and (3) in other instances where risks are
low, field trial requirements should still minimize unauthorized
releases of gene products, but a low level of GE crops in the
environment could be found acceptable if available data find that they
meet applicable regulatory standards. Following that announcement,
USDA, EPA, and FDA published notices concerning their responsibilities
regarding field trials and the low-level presence of regulated GE
material. Specifically:
* In March 2007, USDA published its current policy for responding to
low levels of regulated GE plant materials that may occur in commercial
seeds or grain. For example, USDA may determine that remedial action is
not necessary when (1) the regulated material is derived from plants
that meet all of the criteria to qualify for USDA's notification
process and (2) the regulated GE crop is similar to another GE crop
that has already been deregulated by USDA. USDA also stated that it
could take enforcement action against violators of regulations, even if
it decided that no remedial actions were necessary to address the low-
level presence of regulated GE material in commerce.
* In May 2007, EPA released guidance for small-scale field testing and
the low-level presence of GE pesticides in food. EPA stated if there is
any reasonable expectation that residues of the GE pesticide being
tested could enter the food supply, even at low levels, all crops
affected by such tests must either be destroyed or be kept from the
food or feed supply while additional studies using the crop are
conducted, or the applicant must obtain a tolerance or tolerance
exemption, regardless of the size of the field trial. EPA's policy also
noted the FFDCA provision that a food containing pesticide residues may
not be moved in interstate commerce without an appropriate tolerance or
tolerance exemption. EPA also described methods that developers can use
to isolate GE pesticides from the food or feed supply.
* In June 2006, FDA issued guidance recommending that developers of
certain GE crops intended for food use, but still in the field trial
stage, engage in what the agency called a voluntary early food safety
evaluation, whereby developers would consult with FDA about new GE
materials produced in these plants before they might inadvertently
enter the food supply.[Footnote 5] If FDA had already reviewed the GE
material and had no safety concerns, the agency did not expect
developers to participate. FDA has conducted seven such evaluations
since 2006. FDA officials said the agency does not use data from USDA's
permits database to identify field trials that might be candidates for
FDA's early food safety assessments; instead FDA relies on developers
for notification. In this guidance, FDA stated that "consistent with
confidentiality requirements," it would make the developers'
submissions and FDA's responses easily accessible to the public via the
Internet. However, FDA has not done so. Agency officials indicated that
they intend to fulfill this commitment to make submissions available
online, but FDA has not had the resources to post the submissions.
Routine Interagency Coordination of Programs Occurs, but Opportunities
Exist for Further Coordination among the Agencies:
USDA, EPA, and FDA have organizational structures and mechanisms in
place to coordinate their oversight and regulation of biotechnology,
but opportunities exist for further coordination and collaboration
among the agencies. Using as criteria practices we have identified in
prior work that can enhance and sustain collaboration among federal
agencies, we found that agencies have agreed on roles and
responsibilities and have established compatible policies, procedures,
and other means to operate across agency boundaries. However, the
agencies could enhance their coordination by further leveraging
resources, developing mechanisms to monitor and evaluate results, and
implementing other practices. While we have identified areas for
improvement, most of the officials with whom we spoke did not indicate
that they had major concerns about the adequacy of interagency
coordination, nor did they identify changing the Coordinated Framework
as a high priority.
Agencies Could Enhance Coordination by Further Leveraging Resources,
Developing Mechanisms to Monitor and Evaluate Results, and Implementing
Other Practices:
GAO has previously identified a set of eight practices that can enhance
and sustain collaboration among agencies.[Footnote 6] Seven of these
practices are as follows:
* Defining and articulating a common outcome.
* Agreeing on roles and responsibilities.
* Establishing mutually reinforcing or joint strategies.
* Identifying and addressing needs by leveraging resources.
* Establishing compatible policies, procedures, and other means to
operate across agency boundaries.
* Reinforcing agency accountability for collaborative efforts through
agency plans and reports.
* Developing mechanisms to monitor, evaluate, and report on the
results.
We evaluated the degree of coordination and collaboration among USDA,
EPA, and FDA in their oversight of GE crops according to each of these
practices.
Defining and Articulating a Common Outcome:
The three agencies are working toward the broad common outcome that was
originally described in the Coordinated Framework. The document sought
to achieve a balance between developing regulations adequate to ensure
health and environmental safety and maintaining sufficient regulatory
flexibility to avoid impeding the growth of the nascent biotechnology
industry. To arrive at this outcome, the Coordinated Framework
attempted to distinguish those organisms that require a certain level
of federal review from those that do not. In general, the Coordinated
Framework and subsequent policy statements from OSTP direct federal
agencies to exercise oversight of GE organisms only when there is
evidence of unreasonable risk--that is, when the value of the reduction
in risk obtained by additional oversight is greater than the additional
regulatory costs. Although the types of GE crops that each agency
regulates vary, all three agencies have striven to achieve this common
outcome through the development of risk-based regulatory systems. For
example, USDA's two-tiered permit system, which we previously
described, allows for GE crops that present less risk to be eligible
for the more streamlined notification procedure, rather than a permit.
USDA and EPA have begun other initiatives--which we discuss later in
this report--intended to make their oversight of GE crops more risk-
based. Similarly, because FDA considers most transferred genetic
material to be generally recognized as safe, it does not expect
transferred genetic material to be subject to its food additive
regulation.[Footnote 7]
Agreeing on Roles and Responsibilities:
The agencies have generally agreed on their roles and responsibilities
as they are outlined in the Coordinated Framework, which states that
existing laws provide the basic network of agency jurisdiction and that
jurisdiction over a GE product should be determined by its use. When
these responsibilities overlap, the Coordinated Framework establishes a
lead agency. When incidents of unauthorized release have occurred, the
three federal agencies have taken actions related to their roles and
responsibilities to protect health and environmental safety. For
example, after the most recent unauthorized release, which involved a
regulated GE corn known as Event 32, USDA issued emergency action
notifications for the unauthorized movement of a regulated article, and
EPA issued a "Stop Sale Order" to the developer of the GE corn because
it is illegal to distribute any pesticide not registered under FIFRA.
The three agencies also issued a joint statement in which USDA
concluded that Event 32 poses no plant pest or environmental concerns;
EPA determined that the pesticidal material produced by Event 32 is
identical to that found in an approved GE pesticide and, therefore, it
is covered by an existing tolerance exemption; and FDA concluded there
were no food or feed safety concerns.
Establishing Mutually Reinforcing or Joint Strategies:
The three agencies have taken steps that establish mutually reinforcing
strategies. For example, in 2002, OSTP proposed a mutually reinforcing
joint strategy to address how agencies should respond to a low-level
presence of regulated GE material in the environment or commercial
agriculture. Following OSTP's proposal, USDA issued a notice in the
Federal Register stating its policy for responding to any occurrences
of low-level presence of regulated GE crop materials; EPA released
guidance for small-scale field testing and the low-level presence in
food of GE pesticides; and FDA issued guidance to recommend that
developers of certain GE crops intended for food use but still in the
field test stage engage in what it called a voluntary early food safety
evaluation, as we have previously described. However, OSTP's proposal
was limited in scope to GE crops intended for food or feed use;
pharmaceutical and industrial compounds were not a part of the joint
strategy. Food plants, such as corn and soybeans, are used to produce
these compounds.
Identifying and Addressing Needs by Leveraging Resources:
In 2002, USDA and EPA's Office of Pesticide Programs signed an
agreement intended to leverage agency resources to improve coordination
of federal oversight of GE crops that are engineered to tolerate
herbicide treatments. Under the current regulatory framework, USDA
regulates the herbicide-tolerant GE crop, while EPA regulates
herbicides that are engineered into crops. In the 2002 agreement, USDA
agreed to supply EPA with a list of herbicide-tolerant plants being
field tested each year to ensure that EPA is aware of forthcoming
products, and to provide EPA with a copy of petitions USDA receives
from persons seeking nonregulated status for herbicide-tolerant crops.
USDA also agreed to ask each applicant to submit a voluntary
stewardship plan for the management of pest-resistance and weedy
volunteer crops in herbicide-tolerant crop rotations and to consult
with EPA on the viability of these stewardship plans. For its part, EPA
agreed to supply USDA with current lists of herbicides registered for
use on the crop in question and any readily available information about
their efficacy.
However, we found that USDA and FDA could better leverage agency
resources to address food safety issues for GE crops at the field trial
stage. Specifically, FDA currently relies on GE crop developers to
notify the agency that they are engaged in field trials of a plant with
a novel trait or protein that might benefit from a voluntary early food
safety evaluation. As the federal agency that reviews all applications
for field trials of GE crops, USDA could alert FDA to field trials of
such plants. At the same time, FDA could provide USDA with its
evaluation of important food safety information, such as similarities
between a new protein and known allergens and toxins and the overall
stability of the protein, which USDA could use when making risk
determinations for field trials of GE crops. Food safety concerns are
one of several factors USDA takes into account when considering, for
example, what types of permit conditions are needed for the
environmental release of a GE crop, or whether activities associated
with the crop should qualify for an exemption from the permit
requirement. Currently, however, there are no formal mechanisms for
coordinating the FDA early food safety evaluations with USDA's data on
permits or notifications.
Establishing Compatible Policies, Procedures, and Other Means to
Operate across Agency Boundaries:
Although the specific procedures that the agencies use to regulate
biotechnology vary according to each agency's legal authorities, the
agencies hold interagency meetings to coordinate policies and share
scientific information related to biotechnology across agency
boundaries. There are currently two interagency groups that meet
regularly to coordinate the federal government's oversight of
agricultural biotechnology. One group is responsible for implementing
the administration's policy on agricultural biotechnology and the other
is a technical working group that provides agency officials involved in
the day-to-day implementation of regulations with an opportunity to
discuss emerging issues. These groups are as follows:
* The Interagency Agricultural Biotechnology Working Group. This
working group, cochaired by OSTP and the National Economic Council, was
formed in 2001 to provide a forum for senior-level officials in
relevant executive branch agencies--USDA, EPA, and FDA, the Office of
Management and Budget, and the U.S. Trade Representative--to address
agricultural biotechnology policy.[Footnote 8] According to OSTP, the
Biotechnology Working Group meets once a month or once every 2 months,
as needed. Since its inception, the group has worked on several
interagency initiatives, including coordinating negotiations between
federal agencies to develop a coherent policy to address the low-level
presence in food or feed of regulated GE crops. More recently, the
group provided a forum for senior-level officials to discuss proposed
regulatory revisions, such as the publication of USDA's Draft
Programmatic Environmental Impact Statement and an EPA Advance Notice
of Proposed Rulemaking, to address compliance issues for producers of
GE pesticides. Also according to OSTP, when a major unauthorized
release occurs, this group also provides a venue for officials to
circulate information to ensure that the participating agencies are up
to date on recent developments, and that the federal government's
response is well-coordinated.
* The Interagency Coordinated Framework Technical Working Group. This
working group was formed in 2003 to provide USDA, EPA, and FDA
officials involved in the day-to-day implementation of regulations with
an opportunity to meet monthly via conference call to discuss emerging
issues. The group's past activities have included agency briefings on
new GE products passing their respective approval or consultation
processes, sharing information about upcoming rulemakings, and
discussing lawsuits concerning the regulation of GE agricultural
products.
Reinforcing Agency Accountability for Collaborative Efforts through
Agency Plans and Reports:
The agencies' strategic planning documents and performance reports do
not specifically focus on the Coordinated Framework or the broad
principles underlying the current regulatory system. However, these
documents do address emerging issues related to biotechnology and
recognize the need for interagency collaboration where appropriate. For
example, USDA and FDA defined and measure their progress toward the
shared goal of supporting international capacity building for
agricultural biotechnology and promoting science-based oversight. In
its strategic plan for 2005 through 2010, USDA established the goals of
providing technical assistance and training to help countries adopt
U.S. approaches to agricultural trade policy and helping foreign
countries improve their regulatory structure for adopting biotechnology
and agricultural biotechnology products. To measure its progress, USDA
set a target of helping 15 countries make improvements to their trade
policy and regulatory framework by 2010. Similarly, as part of its
yearly report to stakeholders, FDA's Center for Food Safety and Applied
Nutrition identified as priorities for 2007 its serving as the head of
U.S. delegations and providing technical experts to two international
task forces: (1) the Organisation for Economic Co-operation and
Development's (OECD) Task Force on the Safety of Novel Foods and Feeds,
which has worked to harmonize oversight of foods derived from
biotechnology, and (2) the Codex Alimentarius Ad Hoc Intergovernmental
Task Force on Foods Derived from Biotechnology, which has worked to
develop a food safety assessment procedure for the low-level presence
of regulated GE crops.[Footnote 9] FDA also established the goal of
providing technical assistance to the U.S. government on food
biotechnology issues. EPA has been involved in similar initiatives,
including participation on the previously mentioned task forces formed
by OECD and Codex Alimentarius; however, EPA did not discuss these
initiatives in the planning documents and reports that we reviewed.
Developing Mechanisms to Monitor, Evaluate, and Report on the Results:
USDA and EPA have established mechanisms to help evaluate and report on
matters related to the oversight of GE crops. Among the mechanisms
established, USDA formed the USDA Advisory Committee on Biotechnology
and 21st Century Agriculture in 2003 to provide information and advice
to the Secretary of Agriculture on issues related to agricultural
biotechnology. Since its inception, the committee has presented four
consensus reports to the Secretary, including most recently a report on
the issues that USDA should consider regarding the coexistence of GE,
organic, and conventional crops. In addition, in response to USDA's
requests, the National Research Council of the National Academy of
Sciences has provided the agency with three science-based analyses of
emerging issues in biotechnology, including GE crops.[Footnote 10] EPA
also has an advisory committee--the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Scientific Advisory Panel--that, while not
specific to biotechnology, has provided recommendations and peer
reviews related to EPA's oversight of GE pesticides on a number of
occasions. The FIFRA Scientific Advisory Panel, for example, played an
important role in evaluating the health risks associated with the GE
pesticide in StarLink corn.
However, several organizations have concluded that the agencies need
better monitoring to detect unintended environmental or economic
consequences and improve their risk analysis and management of marketed
GE crops. In 2002, the National Research Council concluded that
"screening of all crops with added genetic variation must be conducted
over a number of years and locations because undesirable economic and
ecological traits may only be produced under specific environmental
conditions."[Footnote 11] The council's report contained numerous
recommendations regarding the monitoring of GE crops after they have
been deregulated, including a recommendation that the federal
government establish a long-term monitoring effort to assess potential
environmental changes associated with the commercialization of GE
crops, and that there be an open and deliberative process involving
stakeholders to establish monitoring criteria. Similarly, in 2006, the
National Science and Technology Council[Footnote 12] cited the
monitoring for ecosystem effects associated with the use of GE products
as an area where the federal government could improve its risk
assessments, noting that the ecological consequences are difficult to
predict and that the variety of GE crops and organisms introduced in
the environment is likely to grow.[Footnote 13]
As an example of an unintended environmental consequence, EPA officials
said that the widespread use of herbicide-tolerant GE crops could
accelerate the development of herbicide-tolerant weeds. In this regard,
weed scientists from Iowa State University and the University of
Wisconsin said that federal support for mapping the occurrence of
herbicide tolerance would be helpful. Another possible unintended
consequence of the widespread use of crops containing the GE pesticide
Bt is that Bt could lose its effectiveness against insect pests. As a
condition of registering a Bt pesticide with EPA, registrants must
require that users of the product follow certain insect-resistance
management techniques, including planting "refuges" with non-Bt crops.
[Footnote 14] Registrants determine whether these requirements are met
through surveys of farmers. However, some stakeholders with whom we
spoke raised doubts about the effectiveness of having the registrant of
a GE pesticide perform compliance monitoring activities.
Another concern stemming from the widespread use of GE crops is the
economic impact they might have on farmers growing conventional or
organic crops. For example, some growers of non-GE crops fear that
seeds or pollen containing engineered traits from neighboring fields
may commingle with their crops, thereby making those crops harder to
sell to customers who prefer not to consume GE products. In this
regard, in February 2007, the U.S. District Court for the District of
Northern California ruled that USDA needed to conduct an environmental
impact statement to analyze, among other things, the impact that
deregulating a particular GE alfalfa might have on farmers growing
organic or conventional alfalfa. In a 2008 report to the Secretary of
Agriculture, USDA's Advisory Committee on Biotechnology and 21st
Century Agriculture concluded that fostering coexistence between GE and
non-GE crops is an important and worthwhile goal and acknowledged that
the proximity of GE crops to conventional and organic crops sometimes
causes commingling, preventing some retail consumers from finding
products that are free of GE crops.[Footnote 15] The committee
recommended that the Secretary "take note" of several factors that can
cause commingling, such as the failure to adequately contain regulated
GE crops.
Despite these recommendations and observations from various sources, we
found that USDA, EPA, and FDA do not have a mechanism to monitor,
evaluate, and report on the impact of the commercialization of GE crops
following the completion of the agencies' evaluation procedures. USDA,
the agency with the most comprehensive authority regarding GE crops,
has no systematic program of postmarket oversight. Once GE crops are
deregulated, they are not subject to regulatory control under the Plant
Protection Act, unless USDA finds them to be a plant pest or noxious
weed on the basis of new data or analysis. EPA places conditions on the
use of marketed GE pesticides, but its oversight is largely limited to
the data it collects through the biotechnology developers that register
the products. Without monitoring, undesirable agricultural and
environmental problems could result from the unintended transfer of
genetic material from deregulated GE crops to non-GE crops and other
plants, and these problems could have significant financial
implications.
Similarly, FDA generally does not monitor the use of GE crops in food
or feed once they have been marketed. According to FDA officials, the
agency does not routinely monitor the food supply for the presence of
regulated GE crops because these crops may legally be present in food
and feed, unless they contain an unapproved pesticide or food additive.
In addition, as we have previously reported, monitoring the long-term
health effects of GE food is generally neither necessary nor feasible,
according to scientists and regulatory officials that we contacted.
[Footnote 16] In their view, such monitoring is unnecessary because
there is no scientific evidence, or even a hypothesis, suggesting that
long-term harm (such as increased cancer rates) results from these
foods. Furthermore, there is consensus among these scientists and
regulatory officials that technical challenges make long-term
monitoring infeasible. Experts cited, for example, the technical
inability to track the health effects of GE foods separately from those
of their conventional counterparts. In addition, little is known about
the long-term health effects of consuming most foods, meaning there is
no baseline information against which to assess the health effects
caused by GE foods. However, some stakeholders have expressed food
safety concerns about the potential transfer of genetic material from
food crops used to produce pharmaceutical and industrial compounds (see
the following section on regulatory changes and other initiatives).
While as of July 2008, the use of food crops to produce these compounds
had not moved beyond limited field trials, in the future they may be
produced on a larger scale for commercialization, increasing the
potential for gene transfer to other crops and possible entry into the
food and feed supply. This prospect suggests that some form of limited,
directed monitoring of the food supply may be needed to ensure that
these compounds are not present.
Officials Generally Did Not Cite Interagency Coordination as a Major
Concern or Call for Revisions to the Coordinated Framework:
In general, the officials from 22 stakeholder groups with whom we spoke
did not indicate that interagency coordination was a major concern.
Five officials told us that coordination among the agencies had
improved over time. Nevertheless, some officials identified areas where
interagency coordination could be improved. Most notably, five said
that stronger central leadership, possibly residing in a high-ranking
official, was needed to bring together the relevant agencies and to
provide a unified government response to emerging issues and incidents
as they occur. Two of these officials noted that such leadership
existed in the past but has been inconsistent.
Similarly, the officials with whom we spoke generally did not identify
changing the Coordinated Framework as a high priority. Of those that
expressed an opinion, 10 officials told us that the framework has
worked well and withstood the tests of time. On the other hand, four
officials told us that the Coordinated Framework needed to be revised.
Two of these four individuals, representing consumer advocacy
organizations, said that using existing laws to govern biotechnology,
as called for in the framework, was inadequate because agencies have
had to "creatively interpret" or "bend over backward" to apply laws
that do not specifically address biotechnology. They supported the
creation of new laws specific to biotechnology. Meanwhile, six of the
officials with whom we spoke did not have an opinion on the adequacy of
the Coordinated Framework.
Agencies Are Considering Regulatory Changes and Other Initiatives to
Improve Oversight and Further Limit the Impact of Potential
Unauthorized Releases:
In recent years, USDA, EPA, and FDA have considered changes to which GE
crops they regulate and how they will regulate them with the intention
of improving oversight and reducing the impact of unintended releases
of GE crops. In particular, in its July 2007 draft programmatic
environmental impact statement (DEIS) and its October 2008 proposed
rule, USDA is considering significant changes that could affect, among
other things, which GE crops it regulates, requirements for
pharmaceutical and industrial crops, and the agency's response to
unauthorized releases. Proposals in the DEIS drew mixed views from
stakeholders who submitted comments to the agency; the public comment
period for the proposed rule was ongoing as we completed this report.
Several of these proposed changes in the DEIS related to USDA's
consideration of food safety and public health concerns, and some
stakeholders have commented that USDA did not clearly state how it
would coordinate human health assessments with FDA and EPA. USDA is
also seeking funding to implement a voluntary quality management system
designed to improve industry compliance with its field trial
regulations. In addition, USDA has identified several operational
lessons from its investigation of the LLRICE release that, if acted
upon, could improve oversight. For its part, EPA has proposed amending
several of its GE pesticide regulations, and stakeholders who submitted
comments to the agency generally supported these proposals. Finally,
FDA proposed in 2001 to make its voluntary premarket notification
procedure mandatory; however, as of July 2008, the agency had not taken
action to finalize the proposed rule, despite support from key
stakeholders that we interviewed.
USDA Is Considering Significant Changes in How It Regulates GE crops:
In July 2007, USDA published a DEIS outlining 10 issues related to
biotechnology that may be the subject of future revisions to
regulation. These 10 issues address such matters as which GE crops USDA
should regulate, the permitting and notification process, the
restrictions placed on GE crops that produce pharmaceutical compounds,
and the agency's response to the low-level presence of regulated GE
plant material. For each issue, USDA presented and assessed alternative
regulatory approaches, including a no-action alternative and a
preliminary preferred alternative. (See app. VIII for a list of the 10
issues and the alternatives that USDA assessed for each issue.)
The agency received 77 comments on the DEIS from stakeholders, such as
individuals and organizations representing academia, the biotechnology
industry, public interest groups, agricultural producers, and
government agencies. USDA also received many comments from private
citizens, 265 of which were submitted individually and another 23,379
that were in form letters forwarded by 2 public interest groups. We
analyzed the comments from the 77 stakeholders as well as a random
sample of 51 of the 265 comments submitted individually by private
citizens.[Footnote 17] Using the public comments and other
considerations, USDA issued proposed amendments to its regulations in
October 2008. According to USDA, differences between the proposed rule
and the DEIS are primarily a matter of reorganizing and realigning some
materials and their corresponding regulatory alternatives, using more
descriptive terms in some criteria listed in the alternatives, and
choosing between regulatory alternatives that fall within the analysis
of the DEIS. Changes arising from this rulemaking process could
represent the most extensive overhaul to the regulations since USDA
originally implemented them in 1987. We selected 4 of the 10 issues
addressed by the DEIS that we believe are particularly relevant to
incidents of the unauthorized release of GE crops and analyzed the
comments USDA received. While USDA has requested comments on the
proposed rule, we were not able to review them for this report.
[Footnote 18]
Issue 1: Broadening Regulatory Scope to Include GE Crops Posing Noxious
Weed Risk:
This issue examines the question of which GE crops to regulate. Two
alternatives USDA assessed in relation to this issue--including the one
that the agency indicated was its preliminary preferred alternative--
would expand USDA's oversight to all GE plants, not only those that
pose a risk to plants. These alternatives could also have allowed USDA
the authority to consider the effect of GE crops on public health and
the environment, rather than just the effect on other plants.
In our review of the stakeholder comments submitted to USDA, we found
that 42 of the 44 stakeholders who indicated their preference supported
expanding USDA's oversight. However, stakeholders had varied reactions
to a key difference between the two alternatives--whether USDA should
make regulatory decisions on an "event" or "trait" basis. Regulating by
event would mean regulating each individual insertion or deletion of a
gene or gene fragment from a cell. Regulating by trait would mean
evaluating the characteristic (e.g., herbicide tolerance) manifested in
the crop as a result of genetic engineering, and potentially making
decisions for multiple events that exhibit the same trait. Some of
those who favored regulating by event, which USDA indicated was its
preliminary preferred alternative, believed it would be more
protective. Some of those who favored regulating by trait indicated it
would reduce the regulatory burden on developers. In its October 2008
rulemaking, USDA proposed to regulate GE plants on the basis of (1)
known plant pest and noxious weed risks of the parent plants, (2) the
traits of the GE plant, or (3) the possibility of unknown risks as a
plant pest or noxious weed when insufficient information is available.
Under the proposal, if adopted, USDA would encourage GE plant
developers to consult the agency if they are uncertain whether a GE
plant would be subject to regulation.
At the same time that USDA assessed the impact of expanding the reach
of its regulatory oversight, it also assessed the impact of excluding
certain classes of GE crops from regulatory oversight on the basis of
risk. USDA included this exclusion--which 31 of the 37 stakeholders who
expressed a preference supported--as part of its preliminary preferred
alternative in the DEIS. Some stakeholders who commented on the DEIS
and other observers have suggested that USDA could exclude from
regulation plant pests from which disease-causing genes have been
deleted. An example of a plant pest that is often used in genetic
engineering is a bacterium known as Agrobacterium tumefaciens that can
cause a plant disease known as crown-gall. When used in genetic
engineering, its disease-causing genes are first removed. In the
proposed rule, USDA stated that it anticipates that the range of GE
plants subject to oversight will decrease as the agency reaches the
conclusion that they do not pose increased or unfamiliar plant pest or
noxious weed risks. The proposed rule also contains a procedure whereby
the agency may approve petitions for conditional exemptions from permit
requirements.
Issue 2: Use of Risk-Based Categories for New Products:
Two of the alternatives under this issue that USDA considered in the
DEIS would have expanded its current two-tier system of notifications
and permits to further classify GE crops according to risk. Currently,
USDA's policy allows for GE plants that meet specific eligibility
criteria, such as cases in which the function of the introduced genetic
material is known and does not result in plant disease, to be
introduced under the notification process, while plants that do not
meet the criteria must use the more stringent permit option. Under the
two alternatives, USDA would have clarified and increased the number of
tiers in which GE plants (and other GE organisms) could be placed. The
DEIS proposed four tiers that would account for the potential of a GE
plant to pose plant pest, noxious weed, or food safety risks. The tiers
would impose different procedural requirements and permit conditions on
GE crop developers. According to USDA, an expanded tier system would
increase transparency and help focus agency resources on unfamiliar or
high-risk crops. Almost all stakeholders (45 of 48) who expressed a
preference preferred 1 of the alternatives that would expand the
current 2-tiered system, with the remaining 3 stakeholders preferring
that USDA abolish all categories and evaluate all field trial
applications on a case-by-case basis. USDA's October 2008 proposed rule
is consistent with the DEIS in that it would eliminate the notification
procedure. USDA would continue to issue three types of permits for
interstate movement, importation, and environmental release. The
permits for environmental release of GE plants would be sorted into one
of four categories on the basis of risk.
Issue 4: Regulation of Crops Producing Pharmaceutical and Industrial
Compounds:
USDA also assessed in its DEIS several alternatives for modifying its
approach to issuing field trial permits for GE crops not intended for
food or feed--namely, those engineered to produce pharmaceutical and
industrial compounds. Currently, USDA imposes more stringent
confinement and inspection requirements on these crops than it does for
other types of GE crops. If unintentionally released into the food or
feed supply, GE crops producing pharmaceutical and industrial compounds
may pose risks to human health, trade, and the environment that are not
posed by other types of GE crops, such as herbicide-resistant or insect-
tolerant crops. USDA outlined a number of possible alternatives, such
as prohibiting outdoor field tests of these crops or allowing only
nonfood crops, such as tobacco, to be engineered to produce those
compounds under the assumption that they would not be consumed
inadvertently. Its preferred alternative was to continue to allow food
and feed crops to be used for the production of pharmaceutical and
industrial compounds, imposing confinement requirements as appropriate.
About half (27 of 52) of those stakeholders who expressed a preference,
including all of the biotechnology developers and the majority of the
academics and governmental organizations, preferred that USDA continue
to allow food and feed crops (such as corn) to be used for the
production of pharmaceutical and industrial compounds, but impose
confinement requirements on the basis of the risk posed by the organism
and consider food safety in setting permit conditions. However, 12
preferred that USDA prohibit outdoor field testing of GE crops
engineered to produce pharmaceutical or industrial compounds if the
type of crop used also has food or feed uses because of concerns that
outdoor testing would increase the probability of those compounds
spreading into the food or feed supply. Another 10 preferred that USDA
prohibit outdoor field testing of any GE crop that produces these
compounds. The remaining 3 advocated prohibiting the use of food and
feed crops, regardless of whether the crop is grown in an outdoor field
test or in a contained facility. Of all of the issues discussed in the
DEIS, this is the one that most concerned private citizens. The Union
of Concerned Scientists and the Center for Food Safety forwarded almost
23,400 comments from private citizens urging USDA to ban the outdoor
production of pharmaceutical and industrial compounds in food crops. In
its proposed rule, USDA concluded that its proposed permitting
procedures and the use of stringent permit conditions can effectively
minimize the risks that might be associated with the environmental
release of GE plants that produce pharmaceutical or industrial
compounds, including GE plants that are normally food crops.
Issue 7: Allowance for Low-Level Presence of Regulated GE Material in
Crops, Food, Feed, or Seed:
Under this issue, USDA's DEIS evaluated alternatives that would
establish criteria for determining that an unauthorized release of a
low level of regulated GE crops outside of a field trial site is
"nonactionable"--that is, determining when a GE crop poses a low risk
to health or the environment. Currently, the agency's policy is to
respond to incidents of low-level presence on a case-by-case basis,
assessing the specific health and environmental risks posed by the
regulated material and taking remedial action only when necessary. In
its DEIS, USDA proposed specific criteria under which the agency would
not take remedial action in response to unauthorized releases that pose
minimal risk, contending that these criteria would reassure the public
and other countries of the safety of any regulated GE crops detected at
low levels in commercial plants or seeds. The majority of stakeholders
(34 of 46) who expressed a preference supported establishing criteria
for determining when a release is nonactionable. A number of academic
stakeholders attributed the market disruptions that followed
unauthorized releases to a perception of risk created by the current
regulations, which treat all releases alike. Some stakeholders also
noted that tolerances have been developed to allow for low levels of
contaminants, such as pesticides or insect parts, in the food supply,
and that USDA should be able to develop similar tolerances for GE crops
that pose no known risk to human health. In addition, some stakeholders
supported the relaxation of confinement standards in some instances,
arguing that the low-level presence of genes moving from a GE plant to
a non-GE plant should not, in itself, be a concern because gene flow is
a pervasive and naturally occurring process.
However, other stakeholders (7 of 46), namely public interest groups
and agricultural producers, supported the most stringent of the
proposed alternatives, which would impose confinement requirements on
all GE crops comparable to those now imposed on pharmaceutical and
industrial crops and would consider all low-level presence to be
actionable. These stakeholders argued that trace amounts of regulated
material could jeopardize organic agriculture, particularly in export
markets that have tighter standards, and that USDA does not have
sufficient scientific data on the long-term effects of GE crops to make
the determination that low levels are safe. The private citizens whose
comments we analyzed and who expressed a preference also preferred this
alternative.
USDA's October 2008 proposed amendment to its regulations is generally
consistent with the preliminary preferred alternative in the DEIS. USDA
proposes to investigate each incident of low level presence
individually before making a decision on what, if any, remedial action
is needed. USDA would use specific criteria enumerated in the proposed
regulations to rate the risk involved in the incident. However, those
criteria would not fully determine the agency's response; USDA would
evaluate other relevant information and order remedial action if it
appears necessary.
Stakeholders Raised Concerns That USDA Did Not Clearly State How It
Would Coordinate Human Health Assessments with EPA and FDA:
Four of the 10 issues described in USDA's DEIS referred to the agency's
consideration of food safety and public health concerns associated with
GE crops, and some stakeholders thought it was unclear whether it would
be USDA's, EPA's, or FDA's responsibility to perform the necessary
evaluations. These 4 issues are as follows:
* In issue 1, regarding the broadening of USDA's scope of oversight of
GE crops, as we have previously discussed, USDA's preliminary preferred
alternative in its DEIS as well as its proposed regulatory amendment
would use the agency's authority to consider the effect that GE crops
could have on public health. To date, USDA has regulated GE crops on
the basis of their risk as a plant pest--it takes into consideration
human health data when responding to petitions to deregulate GE crops
to meet NEPA requirements, but FDA has primary responsibility for food
safety. Under its proposed rule, USDA would use its authority under the
Plant Protection Act to regulate GE crops as potential noxious weeds,
which would enable it to regulate crops on the basis of their effect on
public health. For example, it could consider public health in setting
the conditions for field trials of GE crops and could require that all
food safety issues be resolved prior to deregulation. However, the
agency did not provide specific details in either the DEIS or the
proposed rule on how it intends to evaluate human health effects or
determine when food safety issues have been resolved.
* In issue 2, USDA's preliminary preferred alternative in the DEIS, as
well as its proposed regulatory amendment, would include human health
as a criterion for determining which category a GE crop would fall into
under the proposed risk-based system. For example, according to the
DEIS, to qualify for the lowest risk tier, a GE food would need an EPA-
issued pesticide tolerance or an alternative evaluation of its toxicity
and allergenicity. In general, under its preferred alternative, USDA
would consider the toxicity and allergenicity of GE crops when imposing
confinement requirements on field test sites. However, USDA did not
specify which agency would evaluate toxicity or allergenicity.
* In issue 4, USDA's DEIS described several alternatives for regulating
crops engineered to produce pharmaceutical and industrial compounds,
including one alternative that would use evaluations of food safety to
determine the appropriate confinement measures, and another alternative
that would require that food safety concerns be addressed prior to the
use of a food or feed crop for the production of such compounds.
However, USDA did not describe the role that FDA or EPA, the agencies
that have primary responsibility for regulating pharmaceutical and
industrial compounds, respectively, would have in providing health
assessments of GE crops used for these purposes.
* In issue 7, USDA indicated in the DEIS that one potential criterion
for determining whether the low-level presence of a regulated GE crop
in the food supply or the environment is nonactionable would be if food
safety issues have been adequately addressed. However, in the DEIS,
USDA did not indicate how it would use food safety assessments from
other agencies, such as FDA or EPA, in deciding whether a low-level
presence is nonactionable. In its October 2008 rulemaking, USDA
proposed that for food and feed crops, one of the following three
conditions must be true for the agency to determine that a low level
presence is nonactionable: (1) EPA has established a tolerance or an
exemption from tolerance for any GE pesticide expressed by the GE
plant, (2) key food safety issues of the new protein or other substance
have been addressed, or (3) no new protein or substance is produced.
A range of stakeholders, including academics, state officials, and
public interest groups, commenting on the DEIS expressed concern that
if USDA decides to evaluate the public health consequences of new GE
crops, its oversight responsibilities would overlap with those of EPA
and FDA. Several stakeholders encouraged USDA to coordinate its
regulatory activities with those of EPA and FDA when addressing human
health concerns. USDA acknowledged that addressing all of the food
safety issues discussed would likely increase these agencies' workload.
USDA's DEIS did not describe how it would incorporate other agencies'
programs, such as FDA's early food safety evaluations of novel
proteins, into its oversight. In addition, FDA's early food safety
evaluations do not apply to crops intended exclusively for the
production of pharmaceutical or industrial compounds. FDA officials
said they had no plans to perform such evaluations in the future.
In its October 2008 proposed rule, USDA acknowledged FDA's authority in
the food safety area, but also emphasized the need for mutual agency
support. USDA stated that it would evaluate permit applications for new
GE organisms, including plants, to determine if they could present
risks to the public health. If so, USDA would contact FDA. The decision
to regulate food and feed from the GE organism would be FDA's. USDA
also stated that it would take into account existing food safety
evaluations when evaluating GE organisms.
USDA Seeks to Establish a Voluntary Biotechnology Quality Management
System to Help Improve Industry Compliance with Field Trial
Regulations:
USDA also is seeking $4.0 million in additional funding for fiscal year
2009 to establish a quality management system to improve developers'
compliance with field trial regulations.[Footnote 19] USDA has
concluded that there is a lack of quality management systems among GE
plant developers, and, in September 2007, the agency announced that it
would establish a voluntary program called the Biotechnology Quality
Management System (BQMS) to help universities, small businesses, and
large companies develop policies and practices that will enable them to
proactively address potential compliance problems before they
materialize. Participants would identify vulnerabilities in their
processes, develop quality control measures to minimize the risk of
unauthorized releases, and demonstrate--through recordkeeping and a
documented management system--their ability to manage the safe
introduction of GE crops into the environment. In addition, USDA would
(1) work with permit holders to ensure that quality management plans
are developed and in place, (2) develop standardized quality assurance
and best practices guidance documents, and (3) provide outreach to the
regulated community. USDA's Agricultural Marketing Service would manage
the audit component of the program and accredit third-party auditors.
However, BQMS would not replace USDA's existing regulatory compliance
and inspection process.
An issue raised by several members of USDA's advisory panel on
biotechnology was whether BQMS's benefits would justify its likely
costs to the government and regulated community. One particular concern
was that the program, while called voluntary, would become an expensive
de facto mandatory program for developers with limited resources, such,
as universities, if agencies used participation in the program as a
criterion for awarding federal funding for GE research. Another concern
was whether there would be adequate incentives to encourage
participation. However, in its 2008 report on coexistence, the advisory
committee also concluded that programs like BQMS may help address
factors that inhibit coexistence among different agricultural
production systems, including the production of GE, conventional, and
organic crops.
USDA Has Identified Lessons Learned from the LLRICE Incidents That
Could Improve Oversight:
In October 2007, USDA issued a compilation of proposed changes intended
to enhance its oversight of GE crops on the basis of lessons learned
from its investigation of the LLRICE incidents and its 20 years of
experience in GE crop regulation. The lessons learned related to a
range of issues, including inadequate record keeping by permit and
notification holders, delays in obtaining representative samples of GE
seed, developers' lack of corrective action plans, incomplete access to
agreements made among GE crop developers and entities they have
contracted with to conduct field trials, and the sufficiency of
isolation distances between field trial sites and other crops. USDA
also noted that it lacked the authority to subpoena anything other than
documents--for example, the agency could not subpoena seeds or plant
parts. The recently enacted 2008 Farm Bill contains language directing
the Secretary of Agriculture to take action on the lessons learned
within 18 months. According to USDA, its October 2008 proposed
rulemaking would address many of the Farm Bill requirements,
particularly as it relates to recordkeeping and reporting. The 2008
Farm Bill also expanded USDA's subpoena authority to cover "tangible
things that constitute or contain evidence."
EPA Has Proposed Amending Its Regulations for GE Pesticides:
EPA is considering amending its regulations governing GE pesticides. In
April 2007, EPA proposed two related rules intended to create a more
risk-based system for regulating a certain type of GE pesticide known
as a plant virus coat protein (PVCP).[Footnote 20] In the first rule,
EPA proposed to exempt from regulation PVCPs that present minimal risk
to human health or the environment. In the second rule, the agency
proposed to exempt from regulation the residues produced by GE
pesticides that are based on viral coat proteins. Under these rules,
developers would be able to self-determine whether a new PVCP-based GE
pesticide is exempt from EPA's pesticide registration requirements and
the requirement of a pesticide tolerance on the basis of specific risk-
based criteria established by EPA. Stakeholders commenting on EPA's
proposed rules had mixed views on the scope of the agency's proposals.
In addition to those that supported the exemptions proposed by EPA,
there were stakeholders from scientific associations that favored
extending the exemption to plant virus genes other than virus coat
proteins, as well as those that favored limiting the exemption to
certain types of PVCP GE pesticides. On the other hand, some comments
from food industry and safety organizations expressed concern about
EPA's proposed exemptions, citing scientific uncertainty.
Also in April 2007, EPA published an advance notice of proposed
rulemaking describing possible revisions that would help EPA account
for the differences between GE pesticides and conventional pesticides
and help ensure that developers of GE pesticides comply with necessary
requirements. According to EPA, current regulations for agricultural
pesticides were written before GE pesticides were defined, and may not
adequately address the distinction. As such, they may not apply to the
unique characteristics of GE pesticides produced in a GE crop on a
farm. Specifically, EPA is considering amending regulations governing
the (1) registration of GE pesticide production facilities, (2)
reporting and record-keeping requirements, (3) issuance of experimental
use permits, and (4) requirements for labeling.
Most stakeholders supported these proposals to distinguish between GE
pesticides and other pesticides. For example, most stakeholders favored
modifying the current definitions in FIFRA relating to GE pesticides,
either by excluding farmers and seed processors from the current
definition of pesticide "producer" and "establishment" or by including
other parties, such as companies that license a GE pesticide for
inclusion in plants, facilities that produce seeds containing GE
pesticides, and any laboratory or greenhouse where a pesticide is
engineered into a plant. However, some stakeholders had varied views
about changes to labeling requirements for GE pesticides. Under current
practices, according to EPA officials, seed labels do not need to
identify that the seed contains a registered pesticide that might have
certain use restrictions. Instead, EPA requires as a condition to
registration that registrants ensure that growers comply with any
planting restrictions associated with the seed. For example, growers
are expected to sign a contract with the registrant of the pesticide
agreeing to certain planting restrictions as well as routine
"compliance assurance visits." While some (4) felt this system was
adequate, others (3) thought a legally enforceable label would help
promote growers' compliance with planting restrictions.
FDA Proposed in 2001 to Make Premarket Notification Mandatory:
In 2001, FDA proposed a rule that would require companies to notify the
agency before marketing GE crops as food or feed products to complement
its voluntary consultations. Among the reasons that FDA cited for
proposing this change were concerns expressed by consumers and public
interest groups about the limits to the transparency and the voluntary
nature of the consultation process and the potential of genetic
engineering to create more complex safety issues. Many stakeholders
with whom we spoke were in favor of this proposal. For example, a
representative from the Grocery Manufacturers Association/Food Products
Association said that food safety assessments should be mandatory and
done early enough so that the public could be assured of product safety
if regulated articles were unintentionally released into the food
supply. Similarly, a representative from the rice industry also said
that food assessments should be mandatory and that if a premarket
notification had been done for LLRICE, it would have reduced the
economic impacts of unauthorized releases. However, as of July 2008,
FDA had not taken action to finalize this proposed rule, and FDA
officials told us that such a rule no longer may be needed because the
voluntary consultation process is working well and fully protects the
public health.
Conclusions:
After two decades of experience with field trials, it is widely
acknowledged that unauthorized releases of regulated material from
field trial sites are likely to occur in the future, and, accordingly,
releases are one area of the Coordinated Framework that has been
reviewed and modernized in recent years. While the OSTP's 2002 policy
document outlines important first steps for agencies to take to address
the likelihood of the low-level presence of regulated genetic material
in the environment or food supply and to mitigate any potential
economic, environmental, or human health consequences, there are two
areas where the agencies could improve their implementation of these
proposals, as follows.
* First, FDA has yet to make publicly available, as was initially
intended, the results of its early food safety evaluations of novel
proteins engineered into plants. In the absence of timely information
about the actual risks to human health and the environment presented by
a GE crop in the field trial stage, FDA may be missing an opportunity
to mitigate the impacts of unauthorized releases, enhance the agency's
credibility, and improve public confidence.
* Second, USDA and FDA have not taken steps to fully leverage their
resources to address food safety issues for certain GE crops at the
field trial stage. While the agencies have acted to implement the
proposals in OSTP's 2002 policy document to address field trials of GE
crops, a lack of coordination of key information among the agencies may
prevent them from making the most effective use of their resources.
Specifically, the agencies do not have a formal mechanism for sharing
information that could enhance their oversight of GE crops in the field
trial stage that contain new proteins and that, if released into the
food supply, could cause health concerns. FDA currently relies on crop
developers to voluntarily notify the agency that they are engaged in
field trials of a plant that might benefit from an early food safety
evaluation. Because USDA, the federal agency that reviews all
applications for field trials of GE crops, does not have a formal
mechanism to alert FDA to field trials of such plants, FDA is less
likely to be aware of developers' activities and to encourage them to
participate in an evaluation. At the same time, without a formal
mechanism for sharing the results of FDA's evaluations, USDA may lack
important food safety information that it could use when making risk
determinations for field trials of GE crops and when setting
confinement and remediation measures.
To date, government oversight of GE crops has largely focused on
assessing and preventing risks posed by GE crops in the testing phase,
assuming that after GE crops enter commercial production, the need to
oversee them diminishes. However, as the volume and variety of GE crops
being grown increases, many stakeholders, including the National
Research Council and the National Science and Technology Council, are
becoming concerned that widespread use of GE crops can have unintended
consequences that should be monitored. The consequences could include
negative effects on the environment, non-GE segments of agriculture, or
food safety. Among the practices we have identified as important to
enhancing collaboration among agencies is developing mechanisms to
monitor, evaluate, and report on the results of agency decisions. Such
mechanisms should be applied to decisions that lead to the commercial
use of GE crops. However, such a monitoring program should be based on
risk. Not all GE crops that are marketed may warrant monitoring, and
the duration of monitoring may not need to be indefinite.
Recommendations for Executive Action:
To improve transparency and mitigate the impact of an unauthorized
release into the food or feed supply of a regulated GE plant that has
completed an early food safety evaluation, we recommend that the FDA
Commissioner fulfill the agency's commitment to post the results of
completed early food safety evaluations on its Web site and add the
results of future evaluations within 120 days of receiving the
submission from the plant developer.
To reduce the risk and impact of unauthorized releases, we recommend
that the Secretary of Agriculture and the FDA Commissioner develop a
formal agreement to share information concerning GE crops with novel
genetic traits that, if unintentionally released into the food or feed
supply, present or are likely to present public health concerns and, as
a result, also could have negative financial consequences for the food
and agriculture industry. With information from USDA about permits or
notifications for field trials of such GE crops, FDA could identify
which GE crops might benefit from an early food safety evaluation and
encourage the developers of those crops to participate in evaluations.
With assistance from FDA, USDA could make meaningful and transparent
use of the health evaluation data available through FDA's early food
safety evaluations in its risk assessment of GE crops.
To help ensure that unintended consequences arising from the marketing
of GE crops are detected and minimized, we recommend that the Secretary
of Agriculture, the EPA Administrator, and the FDA Commissioner develop
a coordinated strategy for monitoring marketed GE crops and use the
results to inform their oversight of these crops. Such a strategy
should adopt a risk-based approach to identify the types of marketed GE
crops that warrant monitoring, such as those with the greatest
potential for affecting the environment or non-GE segments of
agriculture, or those that might threaten food safety through the
unintentional introduction of pharmaceutical or industrial compounds
into the food supply. The strategy should also identify criteria for
determining when monitoring is no longer needed. In developing a
strategy, the agencies should draw upon the analysis and conclusions of
the National Research Council and the National Science and Technology
Council.
Agency Comments and Our Evaluation:
We provided a draft of this report to USDA, EPA, and the Department of
Health and Human Services (FDA) for review and comment. USDA and FDA
provided written comments; these comments are reproduced in appendixes
II and III, respectively. EPA provided its comments orally. The
agencies generally agreed with the report's findings. FDA and EPA also
provided technical comments that we have incorporated as appropriate.
In addition, we provided a draft of this report to the Office of the
United States Trade Representative for informal review and comment.
This Office responded that it had no comments on the report.
Concerning our first recommendation, FDA said that it intends to make
every effort to fulfill its commitment to post the results of completed
early food safety evaluations on its Web site and add the results of
future evaluations within 120 days of receiving the submission from the
plant developer. However, FDA also said that activities of greater
public health priority have been the focus of its limited resources.
While acknowledging these priority and resource considerations, we
continue to believe that implementing this recommendation would be a
relatively low-cost way to increase public transparency and trust and
mitigate the impact of the unintended release of GE crops subject to
early food safety evaluations.
Regarding our second recommendation, USDA and FDA agreed, in part, that
developing a formal agreement could enhance the sharing of information
concerning GE crops with novel genetic traits that, if unintentionally
released into the food or feed supply, could cause health concerns and
have negative financial consequences. For example, USDA stated that
information obtained from FDA under this agreement could assist USDA in
its decisions on confinement conditions and deregulation of certain GE
organisms. FDA also said that it would be useful to explore possible
mechanisms for sharing information with USDA. However, the agencies
said they should focus their resources on issues that present or are
likely to present public health concerns rather than issues that pose
only "perceived" concerns. In addition, regarding the financial
consequences of unintended releases, FDA said this possibility falls
outside the scope of its authority to protect and promote the public
health. However, we note that USDA, which bears some responsibility for
promoting and expanding agricultural markets, may be concerned with
these consequences. Because sharing such information would be
beneficial, we retained the reference to the financial consequences of
unintended releases in the recommendation. As we reported, the known
unintended releases of GE crops into the food or feed supply apparently
have not caused health effects, but several led to financial losses.
Nonetheless, we modified this recommendation to remove the reference to
"perceived health concerns" and instead emphasize that the agreement
would cover GE crops that present or are likely to present public
health concerns.
USDA, EPA, and FDA agreed, in part, with the third recommendation that
they develop a coordinated strategy to monitor marketed GE crops for
unintended consequences. USDA stated that it supports having
discussions with EPA and FDA regarding monitoring strategies for
marketed deregulated GE crops. While USDA agreed that monitoring a
partially deregulated GE crop might be appropriate where a potential
plant pest risk is identified, USDA said its current regulations limit
it to monitoring only regulated crops, and only for plant pest risks.
We note that USDA maintains authority under the Plant Protection Act to
regulate GE crops that it previously deregulated if it obtains new
information indicating the crop is a plant pest. We also note that USDA
has authority under the Plant Protection Act to regulate GE crops as
noxious weeds, if warranted. Finally, in light of known unauthorized
releases that led to financial losses, we believe that USDA should
contribute to monitoring for other unintended consequences, such as
economic impacts on other agriculture sectors, such as organic crops,
that may become contaminated by GE crops. Also regarding monitoring
strategies for marketed deregulated crops, EPA said that it intends to
discuss such coordination issues with USDA and FDA to be better
prepared in case a situation should arise in the future that warrants
monitoring and is willing to continue working with the other agencies
to determine whether additional monitoring mechanisms are worthy of
consideration, how such monitoring would be conducted, and what
resources would be required. However, EPA opined that GE crops that
produce pesticides do not require any post-market monitoring beyond
what is currently in place. For example, EPA noted that companies are
required by FIFRA to report any adverse effects associated with GE
pesticides and, in some cases, EPA has required companies holding
registrations for GE pesticides to conduct studies on their effects.
While acknowledging these monitoring mechanisms already in use, we
still believe the agencies need a coordinated strategy for monitoring
marketed GE crops that could include, in part, these mechanisms. FDA
said that post-market monitoring of foods derived from GE crops is not
necessary, but that it would consider risk-based monitoring should
marketed GE crops intended for food or feed warrant such scrutiny in
the future. FDA also indicated that it plans to discuss coordination
issues with the other agencies to be better prepared should such a
situation arise. In making this recommendation, our concern, in part,
was the potential for GE crops producing pharmaceutical or industrial
substances to be inadvertently present in the food or feed supply. In
that regard, FDA opined that random sampling to detect pharmaceutical
or industrial substances would present significant technical challenges
and greatly affect resources and would be less effective than USDA's
current system of strict permit conditions and inspections targeted to
GE crops used to produce these substances. However, given that in the
United States (1) GE crop varieties are grown extensively, (2) most
processed foods contain ingredients from GE crops, (3) it is inherently
difficult to prevent the spread of plant genetic material in the
environment, (4) there may be an increasing use of GE crops to produce
an even wider array of pharmaceutical and industrial compounds in the
future, and (5) genetic modifications are becoming increasingly complex
in response to pressures to increase yields for food and biofuel, we
stand by our recommendation that the agencies should develop a
coordinated strategy for risk-based monitoring of marketed GE crops.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we will plan no further distribution until 30
days from the report date. At that time, we will send copies of this
report to the appropriate congressional committees; the Secretary of
Agriculture; the Administrator of EPA; the Secretary of Health and
Human Services; the Commissioner of FDA; the Director, Office of
Management and Budget; and other interested parties. Copies of this
report will be made available to others upon request. In addition, this
report will be available at no charge on GAO's Web site at [hyperlink,
http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. Key contributors to this report are
listed in appendix IX.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
At the request of the Chairman and Ranking Member, Senate Committee on
Agriculture, Nutrition, and Forestry, we evaluated federal oversight of
genetically engineered (GE) crops. Specifically, our objectives were to
examine (1) unauthorized releases of GE crops into food, feed, or the
environment; (2) the degree of coordination among the federal agencies
that regulate GE crops under the 1986 Coordinated Framework for
Regulation of Biotechnology (Coordinated Framework); and (3) additional
actions the agencies have proposed to improve the oversight of GE crops
and reduce the potential for unauthorized releases. The focus of our
work was on the federal regulation of GE crops. We did not assess
regulation of GE animals or other nonplant organisms. In addition, we
did not assess U.S. efforts to reduce barriers to international trade
in GE agricultural commodities.
In general, to achieve our objectives, we interviewed officials or
obtained documentation from relevant federal agencies, including the
U.S. Department of Agriculture (USDA); Environmental Protection Agency
(EPA); Food and Drug Administration (FDA), and Office of Science and
Technology Policy (OSTP) which is within the Executive Office of the
President, as well as from agriculture and food industry and consumer
organizations. Industry organizations included the American Farm Bureau
Federation, American Seed Trade Association, American Soybean
Association, Association of Official Seed Certifying Agencies, Grocery
Manufacturers' Association/Food Products Association, National
Association of Wheat Growers, National Corn Growers Association,
National Grain and Feed Association, North American Export Grain
Association, Organic Trade Association, U.S. Soybean Export Council,
and USA Rice Federation. Consumer organizations included the Center for
Food Safety, Center for Science in the Public Interest, Consumers
Union, and Union of Concerned Scientists. In addition, we interviewed
officials or obtained documentation from the Biotechnology Industry
Organization; biotechnology companies, such as Arborgen and Monsanto;
academics involved in genetic engineering research; the National
Research Council; and the Pew Initiative on Food and Biotechnology.
More specifically, to examine unauthorized releases of GE crops into
food, feed, or the environment, we reviewed government documents,
academic literature, and media accounts related to known incidents of
releases. We also discussed these incidents and their potential
environmental, financial, health, and trade implications with industry,
consumer, and academic officials. Furthermore, to examine the federal
government's role in preventing unauthorized releases and mitigating
their impact, we reviewed relevant laws and regulations and discussed
their implementation with USDA, EPA, and FDA officials. At USDA, we
also reviewed data on field trial permits and inspections done during
fiscal years 2005 through 2007, and data on suspected violations and
enforcement actions taken during fiscal years 2003 through 2007. In
addition, we reviewed case files on potential incidents of unauthorized
releases reported during fiscal years 2003 through 2007 that were
referred for investigation. We also reviewed a random sample of other
case files that were resolved without an investigation during this
period. In addition, at EPA, we reviewed data on field trial permits
issued from fiscal year 1997 through May 2008, and documentation on the
four enforcement actions taken from fiscal year 1996 through August
2008. Since EPA had delegated enforcement authority, including the
responsibility for doing field trial inspections to all 50 states
except Wyoming, the agency was unable to provide us with summary data
on the number of completed inspections involving GE pesticides.
To determine the degree of coordination among agencies that regulate GE
crops, we reviewed the Coordinated Framework's guidance for interagency
coordination. We then discussed with agency officials their
implementation of this guidance and reviewed documents that they
provided, such as interagency memorandums of understanding and agendas
or minutes for interagency meetings. We also considered the views of
nongovernmental organizations regarding the adequacy of this
coordination, including those published by the National Research
Council and the Pew Initiative on Food and Biotechnology. In addition,
for criteria, we applied selected practices previously identified by
GAO for enhancing and sustaining interagency collaboration.[Footnote
21] These practices include defining and articulating a common outcome;
agreeing on roles and responsibilities; establishing mutually
reinforcing or joint strategies; identifying and addressing needs by
leveraging resources; establishing compatible policies, procedures, and
other means to operate across agency boundaries; developing mechanisms
to monitor, evaluate, and report on results; and reinforcing agency
accountability for collaborative efforts through agency plans and
reports. We did not address an eighth practice--that is, reinforcing
individual accountability for collaborative efforts through performance
management systems--because doing so was beyond the scope of our work.
Related to the coordination issue and other aspects of the Coordinated
Framework, we also compared the guidance contained in the framework and
in related policy statements subsequently issued by OSTP with
regulations and proposed rules promulgated by USDA, EPA, and FDA since
1986. In addition, we discussed the framework's relevance with
industry, consumer, and academic officials. Although the framework is a
broad policy document addressing all aspects of biotechnology, our
analysis was limited to those sections that pertain specifically to the
regulation of GE crops.
To determine the additional actions proposed by the agencies to improve
oversight of GE crops and reduce the potential for unauthorized
releases, we reviewed relevant proposed rules published in the Federal
Register. These proposed rules included the following:
* USDA, Proposed Rule: Importation, Interstate Movement, and Release
Into the Environment of Certain Genetically Engineered Organisms, 73
Fed. Reg. 60,008 (Oct. 9, 2008).
* USDA, Introduction of Genetically Engineered Organisms, Draft
Programmatic Environmental Impact Statement, (July 17, 2007).
* EPA, Proposed Rule: Exemption from the Requirement of a Tolerance
under the Federal Food, Drug, and Cosmetic Act for Residues of Plant
Virus Coat Proteins that are Part of a Plant-Incorporated Protectant
(PVC-Proteins), 72 Fed. Reg. 19,640 (Apr. 18, 2007).
* EPA, Proposed Rule: Exemption Under the Federal Insecticide,
Fungicide, and Rodenticide Act for Certain Plant-Incorporated
Protectants Derived From Plant Viral Coat Protein (PVCP-PIPs) Gene(s)
Supplemental Proposal, 72 Fed. Reg. 19,590 (Apr. 18, 2007).
* EPA, Advance Notice of Proposed Rulemaking: Plant-Incorporated
Protectants; Potential Revisions to Current Production Regulations, 72
Fed. Reg. 16,312 (Apr. 4, 2007).
* FDA, Proposed Rule: Premarket Notice Concerning Bioengineered Foods,
66 Fed. Reg. 4,706 (Jan. 18, 2001).
USDA issued its October 9, 2008 proposed rule after we had sent our
draft report to the agencies for review and comment. We modified our
draft to reflect the publication of the proposed rule, and added brief
descriptions of some aspects of it. However, we were not able to
thoroughly analyze the proposed rule or interview agency or other
stakeholder officials about its contents.
We also reviewed public comments submitted with respect to each of
these proposed rules except USDA's October 2008 proposed rule. (The
deadline for commenting on that proposed rule is November 24, 2008.) In
general, these comments are posted to each rule's official electronic
docket found at Regulations.gov. To summarize the comments on USDA's
draft programmatic environmental impact statement (DEIS), we divided
the respondents into seven constituent categories: academics,
agricultural producers, biotechnology developers, consumer and public
interest groups, food industry representatives, government officials,
and unaffiliated private citizens. A GAO analyst then coded the
responses from the first six constituent categories on the basis of
stakeholders' explicit or implied preference for various alternatives
discussed in the draft statement. The coding scheme included a means of
indicating when a stakeholder's preference was not apparent on the
basis of the written comments. To ensure that decisions about how to
code the comments were reliable, a second GAO analyst also reviewed the
comments. We used the same technique to code a random sample of 51 of
the 265 comments submitted individually by unaffiliated private
citizens.
To summarize the views of stakeholders who commented on EPA's proposed
rules, we coded all stakeholders' comments on the basis of their
general response to the rules as well as their specific responses to
relevant issues identified by EPA. Because of the limited number of
responses--generally about 12--posted in each docket, we did not
stratify respondents into different categories. Regarding FDA's
proposed rule, we could not easily stratify and summarize the
associated comments, which, according to FDA, numbered over 124,000.
Specifically, as of August 2008, FDA had not entered these comments
into an electronic docket that we needed to perform this analysis.
Instead, we reviewed a limited, judgmental sample of these comments to
gain a general understanding of the issues that stakeholders raised.
Furthermore, to determine additional actions proposed by USDA, we
interviewed agency officials and reviewed documentation they provided
related to two initiatives--that is, USDA's (1) proposal for a
voluntary Biotechnology Quality Management System (BQMS) and (2)
summary of lessons learned from its investigation of the unauthorized
release of a GE rice variety, LibertyLink Rice (LLRICE), and other
similar incidents. BQMS, which USDA plans to fully implement in fiscal
year 2009, provides guidance to GE crop developers for analyzing their
field trial operations to identify possible problems and mitigation
measures that could reduce the potential for an unauthorized release.
Also, we attended meetings in November 2007 and March 2008 of USDA's
Advisory Committee on Biotechnology and 21st Century Agriculture at
which the BQMS proposal was discussed.
We conducted this performance audit from July 2007 to November 2008 in
accordance with generally accepted government auditing standards. These
standards require that we plan and perform our audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides this reasonable basis.
[End of section]
Appendix II: Comments from the U.S. Department of Agriculture:
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
USDA:
United States Department of Agriculture:
Office of the Secretary:
Washington, D.C. 20250:
October 31, 2008:
Mr. Jim Jones, Assistant Director:
United States Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Jones:
The United States Department of Agriculture (USDA) appreciates the
opportunity to review and provide comments on the GAO Draft Report,
"Genetically Engineered Crops: Agencies Are Proposing Changes to
Improve Oversight, but Could Take Additional Steps to Enhance
Coordination and Monitoring," (GAO 09-60). We have addressed the
Recommendations for Executive Action that pertain to USDA.
GAO Recommendation:
To reduce the risk and impact of unauthorized releases, we recommend
that the Secretary of Agriculture and the Commissioner of FDA develop a
formal agreement to share information concerning GE crops with novel
genetic traits that, if unintentionally released into the food or feed
supply, could cause real or perceived health concerns and have negative
financial consequences for the food and agriculture industry. With
information from USDA about permits or notifications for field trials
of such GE crops, FDA could identify which GE crops might benefit from
an early food safety assessment and encourage the developers of those
crops to participate in assessments. With assistance from FDA, USDA
could make meaningful and transparent use of the health assessment data
available through FDA's early food safety assessments in its risk
assessment of GE crops.
USDA Response:
USDA agrees, in large part, with this Recommendation. Under the
Coordinated Framework, USDA and the U.S. Food and Drug Administration
(FDA) have worked effectively to share information on this and related
issues. However, development of a formal agreement between USDA and FDA
could enhance relevant information sharing. USDA will work with FDA to
explore the development of an agreement for sharing information to help
ensure that each agency has relevant information concerning regulated
GE crops. USDA recently published a proposed rule to revise existing
regulations regarding the importation, interstate movement and
environmental release of certain genetically engineered (GE) organisms
under the Plant Protection Act (PPA) of 2000. During the comment
period, USDA may receive additional suggestions related to regulations
regarding the importation, interstate movement and environmental
release of certain genetically engineered (GE) organisms under the
Plant Protection Act (PPA) of 2000. During the comment period, USDA may
receive additional suggestions related to enhancing information sharing
with FDA. Information that is shared by FDA under an agreement may
assist USDA in its decisions on confinement conditions and deregulation
of certain GE organisms. Nonetheless, USDA's regulatory system is
science-based, and therefore its evaluations and decision making are,
and will remain, limited to risks involving actual physical harm and
will not consider perceived, but scientifically unfounded, risks. [See
comment 1]
GAO Recommendation:
To help ensure that unintended consequences arising from the marketing
of GE crops are detected and minimized, we recommend that the Secretary
of Agriculture, the Administrator of EPA, and the Commissioner of FDA
develop a coordinated strategy for monitoring marketed GE crops and use
the results to inform their oversight of these crops. Such a strategy
should adopt a risk-based approach to identify the types of marketed GE
crops that warrant monitoring, such as those with the greatest
potential for affecting the environment or non-GE segments of
agriculture, or those that might threaten food safety through the
unintentional introduction of pharmaceutical or industrial compounds
into the food supply. The strategy should also identify criteria for
determining when monitoring is no longer needed. In developing a
strategy, the agencies should draw upon the analysis and conclusions of
the National Research Council and the National Science and Technology
Council.
USDA Response:
USDA agrees, in part, with this recommendation. We support a risk-based
approach to the oversight of regulated GE crops and any monitoring
activities should also be risk-based in order to evaluate potential
impacts on human health and the environment. [See comment 2] However,
our current regulations do not allow for APHIS to base its deregulation
determinations upon any risks other than plant pest risks. Although
USDA deregulation determinations are currently informed by the NEPA
process which analyzes potential impacts on the human environment,
ultimately USDA must deregulate a GE plant when it makes a
determination that the GE plant is unlikely to be a plant pest. After
USDA makes its deregulation determination, it would have no regulatory
basis for further monitoring of the crop. If; however, USDA makes a
partial deregulation determination, then we do agree that monitoring of
the crop may be appropriate in specific circumstances where a potential
for plant pest risk is identified. [See comment 3] We likewise support
having discussions with EPA and FDA regarding the possible parameters
of USDA's involvement in plant pest risk-appropriate monitoring
strategies for marketed deregulated GE crops should such monitoring be
warranted in the future. USDA's overall approach towards monitoring was
explained at length in a 2004 response to two National Research Council
(NRC) reports, issued in 2000 and 2002. In that response USDA explained
that an USDA deregulation is issued when the Agency has determined that
the GE plant varieties do not pose a plant pest risk. This means that
the Agency has found that unconfined release of these deregulated
products is just as safe as that of their non-GE counterparts. Thus,
once USDA has determined that the GE plant crop does not pose a plant
pest risk, then it must remove the GE organism from its regulatory
oversight. [See comment3] If USDA determined that monitoring of a
product was required to mitigate a plant pest risk, USDA could choose
to not deregulate the product or to partially deregulate it with
stringent conditions including possible geographical limitations.
Monitoring requirements could certainly be stipulated in permit
conditions prior to the deregulation of any regulated GE crop.
USDA would like to also note that, as described in detail in the 2004
response to the NRC, there are many USDA programs involved in
activities related to monitoring. [See comment 4] In particular, USDA
risk assessors help to establish priorities and review grants for the
Biotechnology Risk Assessment Grant (BRAG) Program. BRAG is a
competitive grant program administered by USDA's Cooperative State
Research, Education, and Extension Service (CSREES) and the
Agricultural Research Service (ARS). BRAG provides grants for research
on the effects of introducing genetically modified organisms into the
environment. CSREES and ARS also oversee other research programs
related to risk assessment and risk mitigation of GE organisms. The
response to the NRC also reported that in FY2003, ARS funded
approximately $23 million in intramural environmental risk assessment
research. Much of this intramural USDA research was conducted in the
course of developing improved GE varieties. Approximately $4.4 million
of this was specifically earmarked for risk assessment and risk
mitigation research.
USDA also has several long-term programs that track many aspects of
U.S. forest, crop, and range lands. The Forest Service's Forest
Inventory and Analysis periodically gathers data on the status and
trends in forest areas and locations across the United States. Factors
examined include the type and size of trees, soil composition, and
under-story plant diversity. In addition, the National Agricultural
Statistics Service (NASS) conducts surveys and censuses of the Nation's
2.1 million farms. NASS focuses on the type of commodity produced, the
yield, and the cost of production but also collects data on management
practices. Since 2000, NASS has reported on state-by-state adoption
rates of the major GE crops (soybeans, corn, and cotton) in major
producing states and combined adoption rates for other states. Also,
USDA's National Resource Conservation Service (NRCS) collects data on
land use, and soil and water characteristics. Land use data are
collected on 800,000 sites in the United States from satellite images
every five years.
Sincerely,
Signed by:
Bruce I. Knight:
Under Secretary:
Marketing and Regulatory Programs:
The following are GAO's comments on the U.S. Department of
Agriculture's letter dated October 31, 2008.
GAO Comments:
1. USDA commented that its regulatory system is science-based and
limited to risks involving actual physical harm rather than perceived,
but scientifically-unfounded, risks. In light of this comment, we have
modified the wording of our draft recommendation to remove the
reference to "perceived health concerns" and instead emphasize that the
agreement would cover GE crops that present or are likely to present
public health concerns.
2. USDA commented that its regulations do not allow for the Animal and
Plant Health Inspection Service (APHIS) to base its deregulation
determinations upon any risks other than plant pest risks. As USDA
notes in its October 9, 2008 proposed rule, the agency's regulations
could be grounded in more than just its authority to regulate GE crops
as plant pests. The Plant Protection Act gives the Secretary of
Agriculture the authority to regulate to prevent the introduction or
dissemination of noxious weeds. Noxious weeds are defined as any plant
or plant product that can injure or cause damage to, among other
things, crops, livestock, interests of agriculture, public health, or
the environment. In this context, USDA could, for example, monitor
marketed GE crops for their economic effects on other segments of
agriculture.
3. USDA stated that after it makes a decision to deregulate a GE crop
it has no regulatory basis for further monitoring. However, USDA
maintains the authority under the Plant Protection Act to regulate a GE
crop that it has granted deregulated status to if it obtains new
information indicating that the crop is a plant pest. A coordinated
inter-agency monitoring program would be one way of obtaining such
information.
4. USDA listed several programs that it noted are related to
monitoring. We did not review the programs that USDA mentioned, but we
believe that they could provide useful monitoring data related to GE
crops. We suggest that USDA incorporate them into the recommended
coordinated strategy.
[End of section]
Appendix III: Comments from the Department of Health and Human Services
(FDA):
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
October 21, 2008:
Lisa Shames, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street NW:
Washington, DC 20548:
Dear Ms. Shames:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: "Genetically
Engineered Crops: Agencies Are Proposing Changes to Improve Oversight,
but Could Take Additional Steps to Enhance Coordination and Monitoring"
(GAO-09-60).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
Jennifer R. Luong:
For: Vincent J. Ventimiglia, Jr.
Assistant Secretary for Legislation:
Attachment:
Food and Drug Administration General Comments on the Government
Accountability Office's (GAO) Draft Report Entitled, "Genetically
Engineered Crops-Agencies Are Proposing Changes to Improve Oversight,
but Could Take Additional Steps to Enhance Coordination and Monitoring"
(GAO 09-60):
The Food and Drug Administration (FDA) welcomes the Government
Accountability Office's (GAO) draft report on bioengineered foods and
appreciates the opportunity to review and provide comments. In addition
to the FDA's responses to the recommendations, we have provided GAO
with some technical comments regarding the draft report. FDA believes
that its current processes for evaluating bioengineered foods and new
proteins in such foods provides appropriate oversight and protection of
the food and feed supplies. FDA also believes that it closely and
effectively coordinates with the United States Department of
Agriculture (USDA) and the Environmental Protection Agency (EPA) in the
regulation of genetically engineered (GE) food plants. FDA does agree,
however, that certain additional actions would increase transparency
of, and enhance public confidence in, the agency's evaluation
processes.
GAO Recommendations:
To improve transparency and mitigate the impact of an unauthorized
release into the food or feed supply of a regulated GE plant that has
completed an early food safety evaluation, we recommend that the
Commissioner of FDA fulfill the agency's commitment to post the results
of completed early food safety evaluations on its Web site and add the
results of future evaluations within 120 days of receiving the
submission from the plant developer.
FDA Response:
FDA agrees that posting the results of completed early food safety
evaluations on our Web site would improve transparency. As described in
the Guidance to Industry: Recommendations for the Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use, FDA has stated that the agency plans
to respond to a complete submission within 120 days of receipt, and to
make the text of that response letter easily accessible to the public
via the Internet. FDA intends to make every effort to fulfill the
commitments made in the guidance document; however, to date other
activities of greater public health priority have been the focus of the
agency's, and particularly, the Center for Food Safety and Applied
Nutrition's, limited resources. [See comment 1]
GAO Recommendation:
To reduce the risk and impact of unauthorized releases, we recommend
that the Secretary of Agriculture and the Commissioner of FDA develop a
formal agreement to share information concerning GE crops with novel
genetic traits that, if unintentionally released into the food or feed
supply, could cause real or perceived health concerns and have negative
financial consequences for the food and agriculture industry. With
information from USDA about permits or notifications for field trials
of such GE crops, FDA could identify which GE crops might benefit from
an early food safety assessment and encourage the developers of those
crops to participate in assessments. With assistance from FDA, USDA
could make meaningful and transparent use of the health assessment data
available through FDA's early food safety assessments in its risk
assessment of GE crops.
FDA Response:
FDA agrees in part with this recommendation. FDA agrees that it would
be useful to explore possible mechanisms to facilitate information
sharing with USDA to reduce the risk and potential public health impact
of an unauthorized release of a GE crop. In the recent past, USDA and
FDA have worked effectively to share information when an unauthorized
release has occurred. However, the agency intends to explore
development of a formal mechanism to facilitate these exchanges,
recognizing that such a mechanism may make interagency coordination
more transparent and thereby enhance public confidence.
The recommendation suggests that FDA obtain information about GE crops
that, if unintentionally released into the food or feed supply, could
cause "perceived health concerns." FDA uses a risk-based approach that
focuses its resources on issues that either do or are likely to present
public health concerns, as opposed to those issues that present only
"perceived health concerns." FDA believes that focusing its resources
on issues most likely to pose public health concerns provides the
greatest public health protection. In addition, focusing resources on
"perceived health concerns" would divert resources from activities
providing significant public health protection to activities with
little or no discernible public health benefit. [See comment 2]
GAO also suggests that FDA obtain information about GE crops that, if
unintentionally released into the food or feed supply, could have
"negative financial consequences for the food and agriculture
industry." While recognizing that the food and agriculture industry may
experience negative financial consequences in the event of an
unauthorized release of a GE crop, this issue falls outside the scope
of FDA's mandate to protect and promote the public health. [See comment
3]
GAO Recommendation:
To help ensure that unintended consequences arising from the marketing
of GE crops are detected and minimized, we recommend that the Secretary
of Agriculture, the Administrator of EPA, and the Commissioner of FDA
develop a coordinated strategy for monitoring marketed GE crops and use
the results to inform their oversight of these crops. Such a strategy
should adopt a risk-based approach to identify the types of marketed GE
crops that warrant monitoring, such as those with the greatest
potential for affecting the environment or non-GE segments of
agriculture, or those that might threaten food safety through the
unintentional introduction of pharmaceutical or industrial compounds
into the food supply. The strategy should also identify criteria for
determining when monitoring is no longer needed. In developing a
strategy, the agencies should draw upon the analysis and conclusions of
the National Research Council and the National Science and Technology
Council.
FDA Response:
FDA agrees in part with this recommendation. FDA agrees that any
monitoring strategy should adopt a risk-based approach. FDA does not
believe that post-market monitoring of foods derived from GE crops
currently on the market is necessary for the same reasons presented in
the report (p. 35); there is no scientific evidence or even a
hypothesis suggesting long-term harm from consumption of these foods.
FDA would consider specific risk-based monitoring efforts should
marketed GE crops intended for food or feed warrant such monitoring in
the future. FDA intends to discuss coordination issues with USDA and
EPA to be better prepared in case a situation should arise in the
future that warranted such monitoring. [See comment 4]
FDA notes GAO's concern regarding the potential for GE crops producing
pharmaceutical or industrial substances to be inadvertently present in
the food or feed supply (p. 35). As part of the coordinated effort to
regulate such crops, USDA establishes strict permit conditions and
performs rigorous inspections, including an increased rate of
inspections, so that crops producing substances not intended for use in
the food or feed supply do not inadvertently become part of the food or
feed supply. FDA and USDA closely and effectively communicate and
coordinate when there is a concern about the safety of the food or feed
supply. FDA believes that random food product or commodity sampling to
detect GE crops producing pharmaceutical or industrial substances in
food and feed would present significant technical challenges and
greatly affect resources, and would not likely be nearly as effective
as USDA's current system of strict permit conditions and rigorous
inspections targeted toward these crops. [See comment 5]
The following are GAO's comments on the Department of Health and Human
Service's letter dated October 21, 2008.
GAO Comments:
1. FDA commented that it intends to make every effort to fulfill its
commitment to post the results of its early food safety evaluations but
that its focus has been on higher public health priorities. We
recognize that FDA has competing priorities and finite resources, but
we continue to believe that implementing this recommendation would be a
relatively low-cost way to increase public transparency and trust and
mitigate the impact of the unintended release of GE crops subject to
early food safety evaluations.
2. FDA commented that it uses a risk-based approach that focuses its
resources on issues that present or are likely to present public health
concerns as opposed to issues that present only perceived health
concerns. In light of this comment, as well as USDA's similar comment,
we modified the wording of the recommendation to emphasize that the
agencies develop a formal agreement to share information on GE crops
that present or are likely to present public health concerns.
3. We acknowledge FDA's statement that the financial consequences of
unintended releases fall outside it authority to protect and promote
the public health. However, USDA, which bears some responsibility for
promoting and expanding agricultural markets, may be concerned with
these consequences. Thus, while we modified this recommendation to
emphasize sharing information on GE crops that present or are likely to
present health concerns, we also retained reference to the financial
consequences of unintended releases. As we reported, known unintended
releases of GE crops to the food and feed supply apparently have not
caused health effects, but several led to financial losses.
4. FDA commented that it does not believe that post-market monitoring
of foods derived from GE crops currently on the market is necessary.
However, in making the recommendation that the agencies develop a
coordinated monitoring strategy, our concern, in part, is the potential
for GE crops producing pharmaceutical or industrial substances to be
inadvertently present in the food or feed supply. Their presence could
violate the Federal Food, Drug, and Cosmetic Act, could cause harm to
human or animal health, and would likely cause financial harm to the
agriculture and food industry. In light of this possibility, as well as
the likelihood that the use of GE crops to produce these substances
will increase in the future, we believe that the agencies should
develop a risk-based coordinated strategy to monitor for their presence
in the food and feed supply.
5. FDA commented that USDA establishes strict permit conditions and
performs inspections to minimize the likelihood that crops producing
substances not intended for the food or feed supply might inadvertently
become part of that supply, and that random FDA sampling to detect such
substances would be difficult, expensive, and not as effective as
USDA's actions. We acknowledge that USDA imposes strict permit
conditions and requires frequent inspections of GE crops that produce
pharmaceutical and industrial substances. However, while USDA may be
able to reduce the likelihood of unintended releases of these crops,
FDA has primary authority over the safety of the food and feed supply.
Because biological substances such as GE crops are inherently difficult
to control and there may be an increasing use of GE crops to produce an
even wider array of pharmaceutical and industrial compounds in the
future, we continue to believe that FDA and the other agencies should
develop a risk-based coordinated strategy to monitor for their
unintentional release. Furthermore, in the United States (1) GE crop
varieties are grown extensively, (2) most processed foods contain
ingredients from GE crops, and (3) genetic modifications are becoming
increasingly complex in response to pressures to increase yields for
food and biofuel. We believe these factors also argue for risk-based
monitoring.
[End of section]
Appendix IV: U.S. Legal Framework for Regulation of GE Crops:
On June 26, 1986, OSTP published the Coordinated Framework in the
Federal Register.[Footnote 22] The framework describes the
comprehensive federal regulatory policy for ensuring the safety of
biotechnology research and products. According to OSTP, existing
statutes provide a basic network of agency jurisdiction over research
and products and help ensure reasonable safeguards for the public.
While OSTP recognized that the Coordinated Framework might need to
evolve through administrative or legislative actions, it determined
that existing laws would adequately address the regulatory needs for
biotechnology.
The Coordinated Framework outlined the roles and responsibilities of
relevant federal agencies, including USDA, EPA, FDA, the Occupational
Safety and Health Administration, the National Institutes of Health,
and the National Science Foundation. The framework also identified the
relevant laws that would govern those agencies' activities regarding
biotechnology. Table 4 contains summaries of key provisions in the
primary laws that the agencies have used to regulate GE crops as well
as a brief explanation of their relevance to biotechnology. Three of
these laws--administered by USDA, EPA, FDA, or a combination of these
agencies--include the Plant Protection Act; the Federal Insecticide,
Fungicide, and Rodenticide Act; and the Federal Food, Drug, and
Cosmetic Act. In addition, the table contains a summary of the relevant
provisions of the National Environmental Policy Act of 1969; procedures
outlined in that law must be followed by USDA, EPA, and FDA, when
applicable.
Table 4: Key Legislation That Is Relevant to the Regulation of GE
Crops:
Legislation: Plant Protection Act[A]:
General application to GE organisms:
With respect to genetic engineering, USDA currently defines as a
"regulated article" any organism that has been altered or produced
through genetic engineering if the donor organism, recipient organism,
or vector or vector agent belongs to any genera or taxa designated in a
list of plant pests and meets the definition of plant pest or if the
APHIS Administrator determines it is a plant pest or has reason to
believe it is a plant pest. Statutory and regulatory requirements that
apply to plant pests also apply to GE plants that meet the definition
of plant pests.
As described in this report, USDA is considering changes to its
regulations that would also recognize the agency's authority to
regulate GE plants as noxious weeds.
Major relevant provisions:
* Repealed the Federal Plant Pest Act, the Plant Quarantine Act, and
the Federal Noxious Weed Act of 1974, and several other related
provisions. Defines a plant pest as any living stage of a protozoan,
nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid,
infectious agent or other pathogen, or any article similar to or allied
with the foregoing items. Prohibits the importation, entry,
exportation, or movement of any plant pest in interstate commerce,
unless authorized by the Secretary of Agriculture under permit.
* Authorizes the Secretary of the U.S. Department of Agriculture to
allow importation, entry, exportation, or movement of a specific plant
pest without a permit when he or she finds a permit is not necessary.
Allows any person to petition to add or remove a plant pest from the
list of plant pests exempt from the prohibition and directs the
Secretary to act on the petition.
* Authorizes the Secretary to issue regulations to prohibit or restrict
the importation, entry, exportation, or movement in interstate commerce
of any plant product, biological control organism, noxious weed,
article, or means of conveyance if he or she determines it is necessary
to prevent the introduction or dissemination of a plant pest or noxious
weed. Such regulations could include requiring permits or certificates
of inspection. Authorizes the Secretary to publish, by regulation, a
list of noxious weeds prohibited or restricted from entering the United
States or that are subject to restrictions in interstate movement.
* Authorizes the Secretary to, among other things, hold, seize,
quarantine, or destroy any plant, plant pest, noxious weed, biological
control organism, plant product, article, or means of conveyance, if he
or she considers it necessary, to prevent the dissemination of a plant
pest or noxious weed that is new or not widely prevalent in the United
States, and is moving or has moved through the United States or
interstate. States that no plant, plant pest, noxious weed, biological
control organism, plant product, article, or means of conveyance shall
be destroyed unless, in the opinion of the Secretary, there is no less
drastic action that is feasible and that would be adequate to prevent
the dissemination of any plant pest or noxious weed new or not widely
prevalent in the United States.
* Authorizes the Secretary, upon a finding that an extraordinary
emergency exists because of the presence of a plant pest or noxious
weed that is new or not widely prevalent in the United States, to,
among other things, hold, seize, quarantine, or destroy any plant,
plant pest, noxious weed, biological control organism, plant product,
article, or means of conveyance the Secretary has reason to believe is
infested with the plant pest or noxious weed, or to quarantine any
state or portion of a state in which the Secretary finds the plant pest
or noxious weed.
* Authorizes the Secretary to inspect, without a warrant, any person or
means of conveyance moving (1) into the United States to determine if
the person or means of conveyance is carrying an article subject to the
act; (2) in interstate commerce upon probable cause that the person or
means of conveyance is carrying an article subject to the act; or (3)
in intrastate commerce within a state, portion of a state, or premises
that is quarantined as part of an extraordinary emergency upon probable
cause. Authorizes the Secretary to enter any premises in the United
States for conducting inspections or seizures with a warrant issued
upon probable cause that there is an article subject to the act on the
premises. Grants the Secretary power to subpoena the attendance and
testimony of witnesses, the production of all evidence, and the
direction to permit inspections of premises related to the
administration or enforcement of the act. Established criminal and
civil penalties for violations of the act.
* Authorizes the Secretary to issue regulations and orders he or she
considers necessary to carry out the act. Preempts states from
regulating the movement in interstate commerce of any article subject
to the act to control or eradicate a plant pest or noxious weed or to
prevent the dissemination of a biological control organism, plant pest,
or noxious weed if the Secretary has already issued a regulation, or to
prevent the dissemination of the biological control organism, plant
pest, or noxious weed within the United States.
Legislation: Federal Insecticide, Fungicide, and Rodenticide Act[B]:
General application to GE organisms: With respect to genetically
engineered organisms, EPA regulates the pesticides produced in plants,
as well as the genetic material that produces such pesticides. These
pesticides are known as "plant-incorporated protectants." The statutory
and regulatory requirements that apply to pesticides in general--such
as those concerning registration, labeling, experimental use permits,
inspections, and enforcement--also apply to plant-incorporated
protectants produced in GE crops.
Major relevant provisions:
* Unless otherwise authorized by the act, prohibits the selling in any
state of any pesticide that has not been registered under the act, and
authorizes the Administrator of the Environmental Protection Agency to
limit, by regulation, the distribution, sale, or use in any state of
any pesticide that is not registered under the act or is not subject to
an experimental use permit or an emergency exemption. Establishes
procedures to register a pesticide with EPA. Directs the Administrator
to publish guidelines specifying the kinds of information required to
support the registration of a pesticide. Establishes time frames and
procedures for the Administrator to review and approve of registration
applications.
* Permits any person to apply to the Administrator for experimental use
permits for pesticides. Directs the Administrator to review those
applications and either approve the permit or notify the applicant of
the reasons for not issuing a permit. Limits experimental use permits
to when the Administrator determines that the applicant needs such a
permit to accumulate information necessary for registration of a
pesticide under the act. Allows the Administrator to set a temporary
tolerance level for pesticide residues before issuing an experimental
use permit. Allows the Administrator, by regulation, to authorize
states to issue experimental use permits for pesticides.
* Authorizes the Administrator to cancel a pesticide registration if it
appears to the Administrator that the pesticide or its labeling does
not comply with the act, or suspend registration to prevent an imminent
hazard during the time proceedings are pending.
* Prohibits the production of pesticides subject to the act (or an
active ingredient used in producing a pesticide subject to the act)
unless the establishment at which such pesticides are produced is
registered with the Administrator. Authorizes the Administrator to
prescribe regulations requiring producers to maintain records with
respect to their operations and the pesticides produced as the
Administrator determines necessary for the effective enforcement of the
act, and to make those records available for inspection and copying.
Requires producers to permit EPA, upon a valid request, access to and
to copy all records showing delivery, movement, or holding of
pesticides. Authorizes EPA to enter, at reasonable times, any
establishment where pesticides are held for distribution or sale to
inspect and obtain samples. EPA may obtain a warrant from a court of
competent jurisdiction to enter and inspect an establishment or inspect
and copy records when there is reason to believe that provisions of the
act have been violated.
* States that it is unlawful for any person in any state to distribute
or sell, among other things, any pesticide that is not registered
(unless otherwise authorized under the act) or any pesticide that is
misbranded or adulterated. In addition, the act makes it unlawful for
any person to, among other things, fail to prepare and maintain
records, submit reports, or allow inspection under the act. Authorizes
the Administrator to issue "stop sale, use, or removal" orders whenever
a pesticide is found by the Administrator in any state and there is
reason to believe--on the basis of inspections or tests-- that the
pesticide is in violation of the act, or intended to be sold or
distributed in violation of the act. States that unsold pesticides (or
pesticides in unbroken packages) being or having been transported, or
sold or offered for sale in any state in violation of the act, shall be
liable for seizure in any district court in a district where found if,
among other things, the pesticide is misbranded or adulterated or is
not registered under the act. The act also establishes civil and
criminal penalties associated with violations of the act.
* Authorizes the Administrator to exempt federal and state agencies
from the provisions of the act if the Administrator determines
emergency conditions exist that require such an exemption. Authorizes
the Administrator to, by regulation or order, issue requirements and
procedures for persons who store or transport pesticides the
registration of which has been canceled or suspended, for persons who
dispose of stocks of pesticides the registration of which has been
suspended, and for the disposal of any pesticide the registration of
which has been canceled. Directs the Administrator to order a recall of
a pesticide, the registration of which has been suspended or canceled,
if he or she determines the recall is necessary to protect health or
the environment. If the Administrator finds that voluntary recall by
the registrant would be as safe and effective as a mandatory recall,
the Administrator shall request a plan for that recall, and if the plan
is adequate, order the registrant to conduct the recall under the plan.
* Authorizes the Administrator to enter into cooperative agreements
with states and Indian tribes to delegate the authority to cooperate in
the enforcement of the act. Allows states to regulate the sale or use
of federally registered pesticides in the state to the extent the
regulation does not permit any sale or use prohibited by the act.
Allows states to provide registration for additional uses of federally
registered pesticides formulated for distribution and use within that
state to meet special local needs in accordance with the purposes of
the act.
* Authorizes the Administrator to prescribe regulations to carry out
the provisions of the act, and establishes procedures for developing
and finalizing those regulations. Authorizes the Administrator to
exempt, by regulation, any pesticide from the requirements of the act
if he or she determines the pesticide is adequately regulated by
another federal agency or, because of its character, it is unnecessary
to be subject to the act in order to carry out the purposes of the act.
Authorizes the Administrator, after notice and comment rulemaking, to,
among other things, declare a pest, any plant or animal life (other
than man or a bacteria, virus, or other micro-organism on or in living
man or animals) that is injurious to health or the environment and
establish standards with respect to the package, container, or wrapping
in which a pesticide is enclosed.
* Declares that states shall have primary enforcement authority for
pesticide use violations during a period for which the Administrator
determines that the state has adopted adequate pesticide use laws and
regulations, adopted and implemented adequate procedures for
enforcement, and will keep records and reports showing the adoption of
adequate laws and regulations and the adoption and implementation of
adequate procedures. In addition, declares that states that have
entered into cooperative agreements with the Administrator to receive
delegated cooperative enforcement authority will have primary authority
for enforcement, and that the Administrator will have primary
enforcement authority for those states that do not. States that
whenever the Administrator determines that a state with primary
enforcement authority is not carrying out such responsibility, the
Administrator will notify the state. After 90 days, if the
Administrator determines the state's program remains inadequate, the
Administrator can rescind, in whole or in part, the state's primary
enforcement authority.
Legislation: Federal Food, Drug, and Cosmetic Act, as amended[C]:
General application to GE organisms:
All domestic and imported foods and feeds under FDA's jurisdiction,
whether or not they are derived from GE crops, must meet the same
standards. Any food additive, including any introduced through genetic
engineering, cannot be marketed before it receives FDA approval.
However, substances added to foods that are "generally recognized as
safe" under the conditions of intended use do not require FDA approval
to be lawfully marketed. In 1992, FDA determined that most substances
likely to become components of food as a result of genetic engineering
would be the same or similar to substances commonly found in food. FDA
encourages developers of GE foods to voluntarily notify the agency
before marketing the foods. Notification leads to a consultation
process between the agency and the company regarding the safety of the
food in question.
Major relevant provisions:
* Describes the mission of the Food and Drug Administration to, among
other things, protect the public health by ensuring that foods are
safe, wholesome, sanitary, and properly labeled.
* Defines "food" as articles used for food or drink for man or other
animals, chewing gum, and articles used for components of any such
articles. Defines "food additive" as any substance the intended use of
which results or may reasonably be expected to result, directly or
indirectly, in its becoming a component or otherwise affecting the
characteristic of any food, if such substance is not "generally
recognized as safe," as described in the act and implementing
regulations, under the conditions of its intended use. However,
pesticide chemicals and pesticide chemical residues, among other
things, are not considered food additives.
* Prohibits the adulteration or misbranding of any food in interstate
commerce, and the delivery for introduction into or receipt in
interstate commerce of any adulterated or misbranded food. Gives U.S.
district courts jurisdiction to, among other things, enjoin violations
of the prohibitions, or to seize adulterated or misbranded food in
interstate commerce. Provides criminal penalties for violations of
these prohibitions. Authorizes FDA to temporarily detain food when
there is credible evidence or information indicating that such article
presents a threat of serious adverse health consequences or death.
* Deems a food to be "adulterated" when, among other things, the food
bears or contains any poisonous or deleterious substance that may
render it injurious to health; any pesticide chemical residue, unless
the quantity of the residue is within the limits of the tolerance set
by EPA, or an exemption from the requirement of a tolerance is in
effect; or any food additive that is unsafe. (Generally, food additives
are considered unsafe unless a regulation is in effect prescribing the
conditions under which it may be used safely.) Authorizes the
Administrator of EPA to establish tolerances for pesticide chemical
residues in or on food if he or she determines the tolerance is safe.
Authorizes the Administrator to establish exemptions to required
tolerances if he or she determines the exemption is safe.
* Requires those who manufacturer, process, pack, distribute, receive,
hold, or import food (except farms and restaurants) to allow the
Secretary of Health and Human Services (the Secretary) (delegated to
FDA), when there is a reasonable belief that an article of food is
adulterated and presents a threat of serious adverse health
consequences or death, upon written notice at reasonable times and
within reasonable limits and in a reasonable manner, to have access to
and copy all records relating to such article of food needed to assist
the Secretary (delegated to FDA) in determining whether the food is
adulterated and presents such a threat. Authorizes the Secretary
(delegated to FDA) to establish, by regulation, requirements regarding
the establishment and maintenance of records needed to identify the
immediate previous sources and immediate subsequent recipients of food
to address credible threats of serious health consequences or death.
Directs the Secretary (delegated to FDA) to, by regulation, require
facilities that manufacture, process, pack, or hold food for
consumption (not including farms, restaurants, other retail food
establishments, certain nonprofit food establishments, or certain
fishing vessels) to register with the Secretary.
* Authorizes the Secretary (delegated to FDA) to promulgate regulations
for the efficient enforcement of the act, and to conduct examinations
and investigations for the purposes of the act. Authorizes the
Secretary (delegated to FDA), for the purposes of enforcement and upon
written notice, to enter any factory, warehouse or establishment in
which food is manufactured, processed, packed, or held for introduction
in interstate commerce or after such introduction, or to enter any
vehicle being used to transport or hold such food in interstate
commerce. Authorizes the Secretary (delegated to FDA), for the purposes
of enforcement and upon written notice, to inspect, at reasonable
times, and within reasonable limits, and in a reasonable manner, any
factory, warehouse, establishment, or vehicle and all pertinent
equipment, finished and unfinished materials, containers, and labeling
therein.
* Authorizes the refusal of admission of any article of food if, among
other reasons, it appears from examination of samples or otherwise that
such article is adulterated or misbranded. Directs FDA, under certain
circumstances and upon credible evidence or information indicating that
an article of food presents a threat of serious adverse health
consequences or death, to request the Secretary of Treasury to hold
such article for up to 24 hours to enable the Secretary (delegated to
FDA) to inspect, examine, or investigate such article.
Legislation: National Environmental Policy Act of 1969[D]:
General application to GE organisms:
This act requires agencies with oversight responsibility for GE crops
to consider the likely environmental effects of actions they are
proposing, and if those actions would significantly affect the
environment, provide an environmental impact statement. Such statements
could be required for actions related to the regulation of GE crops.
For example, USDA's effort to change its biotechnology regulations is
being conducted under the provisions of the act. USDA also conducts
environmental analyses when it receives a petition to grant
nonregulated status to GE crops.
Major relevant provisions:
* Directs all federal agencies to include a detailed statement of,
among other things, the environmental impact, adverse environmental
effects that cannot be avoided, and alternatives to the proposed action
in every recommendation or report on proposals for major federal
actions significantly affecting the quality of the human environment.
Directs federal agencies to study, develop, and describe appropriate
alternatives to recommended courses of action in any proposal that
involves unresolved conflicts concerning alternative uses of available
resources.
Source: GAO analysis of relevant provisions of these four statutes.
[A] Pub. L. No. 106-224, Tit. IV, §§ 401-442, 114 Stat. 438 (codified
as amended at 7 U.S.C. §§ 7701-7786).
[B] Pub. L. No. 80-104, 61 Stat. 163 (1947) (codified as amended at 7
U.S.C. §§ 136-136y).
[C] Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21
U.S.C. §§ 321-399).
[D] Pub. L. No. 91-190, 83 Stat. 852 (codified as amended at 42 U.S.C.
§§ 4321-4370f).
[End of table]
[End of section]
Appendix V: Summary Information on USDA Notifications and Permits for
Field Trials of GE Crops:
USDA acknowledges notifications submitted by developers seeking to
import, move interstate, or conduct field trials of regulated GE
material, including GE crops, or issues permits. For field trials
involving low-risk GE materials, such as engineering a well-known
protein into a new plant variety, the more streamlined notification
process may be used, assuming other regulatory criteria are met.
However, for higher-risk items, such as engineering an unfamiliar
protein into a new plant, a permit may be required that provides, among
other things, more specific conditions for containment of the GE crop
during the field trial.
From 1987 through 2007, USDA approved over 13,000 notifications and
permits for field trials. Over 90 percent of these approvals were
notifications. Figure 3 shows the number of notifications and permits
that USDA approved annually during this period.
Figure 3: Annual Number of Notifications and Permits Approved by USDA,
1987 through 2007:
[Refer to PDF for image]
This figure is a vertical bar graph depicting the following data:
Annual Number of Notifications and Permits Approved by USDA, 1987
through 2007:
Year: 1987;
Total number of field trial notifications and permits: 9.
Year: 1988;
Total number of field trial notifications and permits: 18.
Year: 1989;
Total number of field trial notifications and permits: 38.
Year: 1990;
Total number of field trial notifications and permits: 57.
Year: 1991;
Total number of field trial notifications and permits: 106.
Year: 1992;
Total number of field trial notifications and permits: 150.
Year: 1993;
Total number of field trial notifications and permits: 306.
Year: 1994;
Total number of field trial notifications and permits: 594.
Year: 1995;
Total number of field trial notifications and permits: 684.
Year: 1996;
Total number of field trial notifications and permits: 626.
Year: 1997;
Total number of field trial notifications and permits: 742.
Year: 1998;
Total number of field trial notifications and permits: 1,085.
Year: 1999;
Total number of field trial notifications and permits: 984.
Year: 2000;
Total number of field trial notifications and permits: 937.
Year: 2001;
Total number of field trial notifications and permits: 1,128.
Year: 2002;
Total number of field trial notifications and permits: 1,141.
Year: 2003;
Total number of field trial notifications and permits: 816.
Year: 2004;
Total number of field trial notifications and permits: 960.
Year: 2005;
Total number of field trial notifications and permits: 891.
Year: 2006;
Total number of field trial notifications and permits: 898.
Year: 2007;
Total number of field trial notifications and permits: 902.
Source: USDA’s Animal and Plant Health Inspection Service.
Note: USDA created the notification process in 1993; prior to that
year, it only issued permits.
[End of figure]
Over time, GE crop developers have conducted field trial experiments on
a variety of characteristics engineered into plants. The
characteristics tested most often have been herbicide tolerance and
insect resistance. Figure 4 presents data on the number of field trials
by the type of characteristic being tested from 1987 through 2007.
Because developers may test more than one characteristic during a field
trial, the total number of characteristics (over 17,000) exceeds the
more than 13,000 approved notifications and permits.
Figure 4: Number of Field Trials by the Genetic Characteristic Tested,
1987 through 2007:
[Refer to PDF for image]
This figure is a vertical bar graph depicting the following data:
Number of Field Trials by the Genetic Characteristic Tested, 1987
through 2007:
Genetic characteristic: Herbicide tolerance;
Total number of approved field trials: 4,427.
Genetic characteristic: Insect resistance;
Total number of approved field trials: 3,774.
Genetic characteristic: Product Quality;
Total number of approved field trials: 3,137.
Genetic characteristic: Agronomic properties;
Total number of approved field trials: 1,880.
Genetic characteristic: Virus resistance;
Total number of approved field trials: 1,298.
Genetic characteristic: Other;
Total number of approved field trials: 956.
Genetic characteristic: Marker gene;
Total number of approved field trials: 847.
Genetic characteristic: Fungal resistance;
Total number of approved field trials: 805.
Genetic characteristic: Bacterial resistance;
Total number of approved field trials: 139.
Genetic characteristic: Nematode resistance[A];
Total number of approved field trials: 44.
Source: Virginia Tech’s Information Systems for Biotechnology.
[A] Nematodes are wormlike organisms.
[End of figure]
[End of section]
Appendix VI: Information on the Commercialization of GE Crops:
If field tests of a new GE crop are successful--for example, the
desired trait, such as herbicide resistance, is expressed, and there
are no unresolved safety issues--developers may seek to commercialize
the product. In general, to do this, developers must petition USDA to
deregulate the GE crop. In turn, to grant this "nonregulated" status,
USDA must determine that the crop does not constitute a "plant pest."
For GE crops engineered to include a pesticidal protectant, the
developer must also obtain a pesticide registration from EPA. Finally,
prior to introducing GE crops into the food or feed supply, developers
are encouraged to consult with FDA on the crops' potential
allergenicity, toxicity, and antinutrient (interference with nutrient
absorption) properties. Assuming these regulatory agencies do not act
to restrict the growth or use of a GE crop, it can enter into the food
or feed supply and mix with conventional (non-GE) varieties without
being monitored, traced, or labeled.
USDA's Deregulation of GE Crops:
Within USDA, APHIS bears the main responsibility for assessing the
environmental safety of GE crops. The primary focus of this agency's
review is to determine whether a plant produced through biotechnology
is a plant pest. Developers can petition the agency to exempt a GE
plant from regulation once they have collected sufficient and
appropriate data regarding the potential environmental impact of a GE
plant. The agency may choose to grant the petition in whole or in part
or to deny the petition. As of July 14, 2008, USDA had received 113
petitions to deregulate regulated GE crops, of which it approved 73.
(See table 5 at the end of this appendix for information regarding the
GE crops addressed by those 73 petitions.) Of the remainder, 12 were
pending, 27 were withdrawn by the petitioner, and USDA identified 1 as
"incomplete." In general, USDA approval of a petition to deregulate
allows the developer to market the product in the United States.
EPA's Registration of GE Pesticides Known as Plant-Incorporated
Protectants:
EPA is responsible for regulating genetic modifications in plants that
protect them from insects, bacteria, and viruses, as well as the
genetic material that causes the pesticide to be produced. These
protectants are subject to the agency's regulations on the sale,
distribution, and use of pesticides. In order for field-testing of
plants with such protectants to be performed on more than 10 acres of
land, EPA must grant an experimental use permit. Prior to
commercialization of a GE plant with such a protectant, EPA reviews the
application for approval of the protectant, solicits public comments,
and may seek the counsel of external scientific experts. For
registrations of new GE pesticides, EPA routinely examines information
regarding the identification of the new genetic material, toxicity or
allergenicity concerns, and possible effects on wildlife. EPA also
evaluates whether the residues of the pesticide in food will be "safe"
and determines whether a tolerance or tolerance exemption can be
issued. Since 1995, EPA has registered 29 GE pesticides engineered into
3 crops--corn, cotton, and potatoes--5 of which have since been
voluntarily canceled.[Footnote 23] All currently registered GE
pesticides have received an exemption from the requirement of a
tolerance, indicating EPA's determination that any level of pesticidal
residue from these crops is safe for food and feed.
FDA's Voluntary Consultation Process for GE Food and Feed Crops:
FDA has primary responsibility for ensuring the safety of most of the
nation's food supply. The Federal Food, Drug, and Cosmetic Act
prohibits the adulteration of food in interstate commerce.[Footnote 24]
In this context, FDA encourages companies developing GE foods to
voluntarily notify the agency before marketing the foods. Notification
leads to a two-part consultation process between the agency and the
company that initially involves discussions of relevant safety issues,
and subsequently involves the company's submission of a safety
assessment report containing a summary of test data on the food in
question.[Footnote 25] The purpose of these test data is to demonstrate
that the GE food item presents no greater risk of allergenicity,
toxicity, or antinutrient properties than its conventional
counterparts. At the end of the consultation, FDA evaluates the data
and may send a letter to the company stating that the agency has no
further questions, indicating in effect that it sees no reason to
prevent the company from commercializing the GE food. Although this
consultation is voluntary, FDA officials said that they are not aware
of any GE food or feed products intentionally marketed to date that
have not gone through the consultation process. As of July 2008, FDA
had completed 72 voluntary consultations on GE crops intended for use
in human food, animal feed, or both; not all of these items were
marketed.
FDA also has regulatory authority over pharmaceutical products derived
from GE crops. These products may be marketed--regardless of whether
the associated GE crops have been deregulated by USDA--only with FDA
approval of a marketing application. However, as of July 2008, FDA had
not received any applications to market pharmaceutical products from GE
crops.[Footnote 26]
Many GE Crops Have Been Marketed for a Variety of Purposes:
Many GE crops have been marketed in the United States and other
countries for a variety of purposes, such as food or feed use. For
example, in the United States, GE varieties accounted for about 80
percent of the corn, 92 percent of the soybeans, and 86 percent of the
cotton planted in 2008. Furthermore, according to food industry
sources, over 70 percent of the processed foods sold in the United
States contain ingredients and oils from GE crops.
However, not all GE crops have been marketed in the United States, and
others were marketed for several years but then were withdrawn from
commercial production. Some of the GE crops marketed in the United
States may also be approved for marketing in other countries. In some
instances, those countries have placed restrictions on the use of these
crops. Table 5 provides information on GE crops granted nonregulated
status by USDA, their approved uses in the United States and other
countries, and their marketing status in the United States.
Table 5: GE Crops Granted Nonregulated Status by USDA and their
Marketing Status in the United States and Other Countries:
GE crop/Institution: Canola/Aventis;
Genetic transformation, or "event,"[A] and trait[B]: MS1&RF1 MS1&RF2
(PGS1); Trait: HT+F;
Commercialized in the United States[C]: Last sold in 2003;
Commercial name[D]: SeedLink Canola;
Approved for: All uses: United States, Australia, Canada, European
Union;
Approved for: Environment: Japan;
Approved for: Planting[E]:
Approved for: Food: China, Japan, New Zealand, South Africa, South
Korea;
Approved for: Feed: China, Japan, South Africa.
GE crop/Institution: Canola/Aventis;
Genetic transformation, or "event,"[A] and trait[B]: Topas 19/2 (HCN92,
HCN10); Trait: HT;
Commercialized in the United States[C]: Last sold in 2003;
Commercial name[D]: [D];
Approved for: All uses: United States, Canada;
Approved for: Environment: Australia, Japan;
Approved for: Planting[E]: Australia;
Approved for: Food: Australia, China, European Union, Japan, Mexico,
New Zealand (HCN92), South Africa, South Korea;
Approved for: Feed: China, European Union, Japan, South Africa.
GE crop/Institution: Canola/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: MS8xRF3; Trait:
HT+F;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Australia, Canada, Japan;
Approved for: Environment: European Union, South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: China, European Union, Mexico, New Zealand, South
Africa, South Korea;
Approved for: Feed: China, European Union, Mexico, South Africa.
GE crop/Institution: Canola/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: T45 (HCN28);
Trait: HT;
Commercialized in the United States[C]: Last sold in 2005;
Commercial name[D]: LibertyLink® Canola;
Approved for: All uses: United States, Australia, Canada;
Approved for: Environment: Japan, South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: China, European Union, Japan, Mexico, New Zealand,
South Korea;
Approved for: Feed: China, European Union, Japan.
GE crop/Institution: Canola/Calgene;
Genetic transformation, or "event,"[A] and trait[B]: PCGN 3828-212/86-
18; PCGN 3828-212/86-23; (23-18-17, 23-198); Trait: OC;
Commercialized in the United States[C]: PCGN 3828-212-86-23 (last sold
in 1998); No: PCGN 3828-212-86-18;
Commercial name[D]: Laurical;
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Canola/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: GT200 (RT200);
Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: Westar Roundup Ready®;
Approved for: All uses: United States;
Approved for: Environment: Canada, Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Japan;
Approved for: Feed: Japan.
GE crop/Institution: Canola/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: GT73 RT73; Trait:
HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Roundup Ready Canola®; or; Westar Roundup Ready®;
Approved for: All uses: United States, Canada, Japan;
Approved for: Environment: Australia, European Union, South Korea;
Approved for: Planting[E]: Australia;
Approved for: Food: Australia, China, European Union, Mexico, New
Zealand, Philippines, South Korea;
Approved for: Feed: China, European Union, Mexico, Philippines.
GE crop/Institution: Chicory/Bejo;
Genetic transformation, or "event,"[A] and trait[B]: RM3-3 RM3-4 RM3-6;
Trait: HT+F;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: European Union;
Approved for: Planting[E]: European Union;
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Cotton/Aventis;
Genetic transformation, or "event,"[A] and trait[B]: LLCotton25; Trait:
HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: LibertyLink Cotton;
Approved for: All uses: United States;
Approved for: Environment: South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand,
South Korea;
Approved for: Feed: Canada, Japan, Mexico.
GE crop/Institution: Cotton/Calgene;
Genetic transformation, or "event,"[A] and trait[B]: 31807/31808;
Trait: HT+IR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Japan;
Approved for: Feed: Japan.
GE crop/Institution: Cotton/Calgene;
Genetic transformation, or "event,"[A] and trait[B]: BXN; Trait: HT;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand;
Approved for: Feed: Australia, Canada, Japan.
GE crop/Institution: Cotton/Mycogen/Dow;
Genetic transformation, or "event,"[A] and trait[B]: 281-24-236; Trait:
IR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Mexico;
Approved for: Feed: Canada.
GE crop/Institution: Cotton/Mycogen/Dow;
Genetic transformation, or "event,"[A] and trait[B]: 3006-210-23;
Trait: IR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Japan, Mexico;
Approved for: Feed: Canada, Mexico.
GE crop/Institution: Cotton/DuPont;
Genetic transformation, or "event,"[A] and trait[B]: 19-51A; Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Cotton/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON1445 MON1698;
Trait: HT;
Commercialized in the United States[C]: Yes: MON1445; No: MON1698;
Commercial name[D]: Roundup Ready®;
Approved for: All uses: United States, Argentina (MON1445), Columbia
(MON1445);
Approved for: Environment: Australia (MON1445), Japan, Mexico, South
Africa;
Approved for: Planting[E]: Australia, Mexico, South Africa;
Approved for: Food: Australia, Canada, China, European Union (MON1445),
Japan, Mexico, New Zealand, Philippines;
Approved for: Feed: Canada, China, European Union (MON1445), Japan,
Philippines.
GE crop/Institution: Cotton/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON15985; Trait:
IR; Commercialized in the United States[C]: Yes;
Commercial name[D]: Bollgard II®;
Approved for: All uses: United States, India, South Africa;
Approved for: Environment: Australia, South Korea;
Approved for: Planting[E]: Australia;
Approved for: Food: Australia, Canada, European Union, Japan, Mexico,
New Zealand, Philippines, South Korea;
Approved for: Feed: Canada, European Union, Japan, Philippines.
GE crop/Institution: Cotton/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON531 MON757
MON1076; Trait: IR;
Commercialized in the United States[C]: Yes: MON531; No: MON1076;
MON757[C];
Commercial name[D]: Bollgard®;
Approved for: All uses: United States, Argentina (MON531), Australia
(MON531), Brazil, China, Colombia (MON531), India (MON531), Mexico,
South Africa (MON531);
Approved for: Environment: Indonesia, Japan, South Korea (MON531);
Approved for: Planting[E]: Indonesia;
Approved for: Food: Canada, European Union (MON531), Japan, New
Zealand, Philippines (MON531), South Korea (MON531);
Approved for: Feed: Canada, European Union (MON531), Japan, Philippines
(MON531).
GE crop/Institution: Cotton/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON88913; Trait:
HT; Commercialized in the United States[C]: Yes;
Commercial name[D]: Roundup Ready® Flex;
Approved for: All uses: United States, South Africa;
Approved for: Environment: Australia;
Approved for: Planting[E]: Australia;
Approved for: Food: Australia, Canada, Japan, Mexico, New Zealand,
Philippines, Singapore, South Korea;
Approved for: Feed: Canada, Japan, Philippines.
GE crop/Institution: Cotton/Syngenta Seeds;
Genetic transformation, or "event,"[A] and trait[B]: COT102; Trait: IR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: [Empty];
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: United States, Australia, New Zealand;
Approved for: Feed: United States.
GE crop/Institution: Flax, Linseed/University of Saskatchewan;
Genetic transformation, or "event,"[A] and trait[B]: FP967; Trait: HT;
Commercialized in the United States[C]: [C];
Commercial name[D]: CDC Triffid;
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: CBH-351; Trait:
HT+IR;
Commercialized in the United States[C]: Last sold in 2000;
Commercial name[D]: StarLink;
Approved for: All uses: [Empty];
Approved for: Environment: United States;
Approved for: Planting[E]: United States;
Approved for: Food: [Empty];
Approved for: Feed: United States.
GE crop/Institution: Maize (corn)/Plant Genetic Systems;
Genetic transformation, or "event,"[A] and trait[B]: MS3; Trait: HT+F;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: MS6; Trait: HT+F;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: T14 T25; Trait:
HT; Commercialized in the United States[C]: Yes: T25; T14: Last sold in
1999;
Commercial name[D]: Liberty Link™;
Approved for: All uses: United States, Argentina, Canada, European
Union (T25), Japan (T25);
Approved for: Environment: Japan (T14), South Korea (T25);
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia (T25), China (T25), Japan (T14), Mexico,
New Zealand (T25), Philippines (T25), Russia (T25), South Korea (T25),
Taiwan (T25);
Approved for: Feed: Australia (T25), China (T25), Japan (T14), Mexico,
Philippines (T25), Taiwan (T25).
GE crop/Institution: Maize (corn)/Dekalb Genetics Corporation;
Genetic transformation, or "event,"[A] and trait[B]: B16 (DLL25);
Trait: HT;
Commercialized in the United States[C]: Last sold in 1999;
Commercial name[D]: [D];
Approved for: All uses: United States, Canada, Japan;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Philippines, South Korea, Taiwan;
Approved for: Feed: Philippines, Taiwan.
GE crop/Institution: Maize (corn)/Dekalb Genetics Corporation;
Genetic transformation, or "event,"[A] and trait[B]: DBT418; Trait:
HT+IR;
Commercialized in the United States[C]: Last sold in 1999;
Commercial name[D]: Bt Xtra™;
Approved for: All uses: United States, Canada;
Approved for: Environment: Argentina, Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, New Zealand, Philippines, South
Korea, Taiwan;
Approved for: Feed: Japan, Philippines, Taiwan.
GE crop/Institution: Maize (corn)/Dow AgroSciences LLC;
Genetic transformation, or "event,"[A] and trait[B]: DAS-06275-8;
(TC6275); Trait: IR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan;
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/Dow AgroSciences LLC/Pioneer Hi-Bred
International Inc.;
Genetic transformation, or "event,"[A] and trait[B]: 59122 (DAS-59122-
7, Event 22); Trait: HT+IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Herculex® RW;
Approved for: All uses: United States, Canada, Japan;
Approved for: Environment: European Union;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, European Union, Mexico, New Zealand,
Philippines, South Korea, Taiwan;
Approved for: Feed: European Union, Mexico, Philippines, Taiwan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: GA21; Trait: HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Roundup Ready®;
Approved for: All uses: United States, Argentina, Canada, Japan;
Approved for: Environment: South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, China, European Union, Mexico, New
Zealand, Philippines, Russia, South Africa, South Korea, Taiwan;
Approved for: Feed: China, European Union, Philippines, Russia, South
Africa, Taiwan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: LY038; Trait: LYS;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan;
Approved for: Planting[E]: Japan;
Approved for: Food: Australia, Japan, Mexico, Philippines;
Approved for: Feed: Australia, Philippines.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON80100; Trait:
IR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for:: Feed: [Empty].
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON802; Trait:
HT+IR;
Commercialized in the United States[C]: [C];
Commercial name[D]: Yieldgard®;
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON810; Trait: IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Yieldgard®;
Approved for: All uses: United States, Argentina, Canada, European
Union, Honduras, Japan, Philippines, South Africa, Uruguay;
Approved for: Environment: Colombia, South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, China, Colombia, Mexico, New Zealand,
Russia, South Korea, Switzerland, Taiwan;
Approved for: Feed: China, Colombia, Russia, Switzerland, Taiwan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON863; Trait: IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Canada, Japan;
Approved for: Environment: South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, China, European Union, Mexico, New
Zealand, Philippines, Russia, Singapore, South Korea, Taiwan;
Approved for: Feed: China, European Union, Philippines, Russia,
Singapore, Taiwan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON88017; Trait:
HT+IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan;
Approved for: Planting[E]: Japan;
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines,
South Korea, Taiwan;
Approved for: Feed: Mexico, Philippines, Taiwan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON89034; Trait:
HT+IR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: Canada, Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan;
Approved for: Feed: Canada, Japan.
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: NK603; Trait: HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Roundup Ready®;
Approved for: All uses: United States, Argentina, Canada, Japan,
Philippines, South Africa;
Approved for: Environment: South Korea, Uruguay;
Approved for: Planting[E]: Uruguay;
Approved for: Food: Australia, China, Colombia, European Union, Mexico,
New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand;
Approved for: Feed: China, Colombia, European Union, Russia, Singapore,
Taiwan, Thailand.
GE crop/Institution: Maize (corn)/Mycogen (Dow AgroSciences); Pioneer
(Dupont);
Genetic transformation, or "event,"[A] and trait[B]: 1507 (TC1507);
Trait: HT+IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Herculex® I;
Approved for: All uses: United States, Argentina, Canada, Japan;
Approved for: Environment: Colombia, Uruguay;
Approved for: Planting[E]: Uruguay;
Approved for: Food: Australia, China, Colombia, European Union, Mexico,
New Zealand, South Korea, Philippines, South Africa, Taiwan;
Approved for: Feed: China, Colombia, European Union, Philippines, South
Africa, Taiwan.
GE crop/Institution: Maize (corn)/Pioneer Hi-Bred International Inc.;
Genetic transformation, or "event,"[A] and trait[B]: 676; 678; 680;
Trait: HT+F;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Maize (corn)/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON809; Trait:
HT+IR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: Japan.
GE crop/Institution: Maize (corn)/Northrup King;
Genetic transformation, or "event,"[A] and trait[B]: Bt11; Trait:
HT+IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Argentina, Canada, Philippines,
South Africa, Uruguay;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, China, European Union, Japan, Mexico,
New Zealand, Russia, South Korea, Switzerland, Taiwan;
Approved for: Feed: Australia, China, European Union, Japan, Mexico,
Switzerland, Taiwan.
GE crop/Institution: Maize (corn)/Syngenta Seeds;
Genetic transformation, or "event,"[A] and trait[B]: MIR604; Trait: IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: Agrisure RW Rootworm-Protected Corn;
Approved for: All uses: [Empty];
Approved for: Environment: United States, Japan, Philippines;
Approved for: Planting[E]: Japan;
Approved for: Food: United States, Australia, Japan, Mexico, New
Zealand, Philippines, South Korea;
Approved for: Feed: Mexico, Philippines.
GE crop/Institution: Maize (corn)/Ciba Seeds;
Genetic transformation, or "event,"[A] and trait[B]: 176; (Bt 176);
Trait: HT+IR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: NaturGard™ KnockOut™;
Approved for: All uses: United States, Argentina, Australia, Canada,
European Union;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: China, Japan, New Zealand, Philippines, South
Africa, South Korea, Switzerland, Taiwan;
Approved for: Feed: China, Japan, Philippines, South Africa,
Switzerland, Taiwan.
GE crop/Institution: Papaya/Cornell University;
Genetic transformation, or "event,"[A] and trait[B]: 55-1/63-1; Trait:
VR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: SunUp, Rainbow;
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada;
Approved for: Feed: [Empty].
GE crop/Institution: Papaya/USDA-Agricultural Research Service;
Genetic transformation, or "event,"[A] and trait[B]: ARS-PLMC5-6(C5);
Trait: VR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: [Empty];
Approved for: Environment: United States;
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Potato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: BT6 BT10 BT12 BT16
BT17 BT18 BT23; Trait: IR;
Commercialized in the United States[C]: BT6: Last sold in 2001; No:
BT10, BT12, BT16, BT17, BT18, and BT23;
Commercial name[D]: Russet Burbank NewLeaf®;
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan, Mexico, Philippines (BT16);
Approved for: Feed: Mexico, Philippines (BT16).
GE crop/Institution: Potato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: ATBT04-6 ATBT04-27
ATBT04-30 ATBT04-31 ATBT04-36 SPBT02-5 SPBT02-7; Trait: IR;
Commercialized in the United States[C]: ATBT04-6: Last sold in 2000
ATBT04-31: Last sold in 2000 ATBT04-36: Last sold in 2000 SPBT02-5:
Last sold in 2001 SPBT02-7[C]; No: ATBT04-27, ATBT04-30;
Commercial name[D]: Atlantic and Superior NewLeaf®;
Approved for: All uses: United States, Canada;
Approved for: Environment: Russia (SPBT02-5);
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, New Zealand, Philippines (SPBT02-
5), Russia (SPBT02-5), South Korea (SPBT02-5);
Approved for: Feed: Australia, Philippines (SPBT02-5).
GE crop/Institution: Potato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: RBMT22-082; Trait:
IR+VR;
Commercialized in the United States[C]: Last sold in 2000;
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, Mexico, New Zealand;
Approved for: Feed: Australia.
GE crop/Institution: Potato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: RBMT21-129 RBMT21-
350; Trait: IR+VR;
Commercialized in the United States[C]: RBMT21-350: Last sold in 2000;
RBMT21-129: Last sold in 2000;
Commercial name[D]: Russet Burbank NewLeaf® Plus;
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines,
South Korea;
Approved for: Feed: Australia, Philippines.
GE crop/Institution: Potato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: RBMT15-101 SEMT15-
02 SEMT15-15; Trait: IR+VR;
Commercialized in the United States[C]: RBMT15-101: Last sold in 2001;
SEMT15-02[C]; SEMT15-15[C];
Commercial name[D]: NewLeaf® Y;
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, Mexico, New Zealand, Philippines,
South Korea;
Approved for: Feed: Australia, Mexico, Philippines.
GE crop/Institution: Rice/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: LLRICE06 LLRICE62;
Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: Liberty Link®;
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Mexico, Russia (LLRICE62);
Approved for: Feed: Canada, Mexico.
GE crop/Institution: Rice/Bayer CropScience;
Genetic transformation, or "event,"[A] and trait[B]: LLRICE601; Trait:
HT;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: [Empty];
Approved for: Environment: United States;
Approved for: Planting[E]: United States;
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Soybean/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: A2704-12 A2704-21
A5547-35; W62 W98; Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: Liberty Link®;
Approved for: All uses: United States (all 5);
Approved for: Environment: Canada (A2704-12), Japan (A2704-12);
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia (A2704-12, A2704-21, A5547-35), Canada
(A2704-12), European Union (A2704-12), Japan (A2704-12), Mexico (A2704-
12, A2704-21, A5547-35), New Zealand (A2704-12, A2704-21, A5547-35),
Russia (A2704-12), South Africa (A2704-12);
Approved for: Feed: Canada (A2704-12), European Union (A2704-12), Japan
(A2704-12), Mexico (A2704-12, A2704-21, A5547-35), South Africa (A2704-
12).
GE crop/Institution: Soybean/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: A5547-127; Trait:
HT;
Commercialized in the United States[C]: No;
Commercial name[D]: Liberty Link®;
Approved for: All uses: United States;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan, Mexico, Russia;
Approved for: Feed: Japan, Mexico.
GE crop/Institution: Soybean/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: GU262; Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Soybean/DuPont Canada Agricultural Products;
Genetic transformation, or "event,"[A] and trait[B]: G94-1 G94-19 G168;
Trait: OC;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, New Zealand;
Approved for: Feed: Japan.
GE crop/Institution: Soybean/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: GTS40-3-2; Trait:
HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Argentina, Brazil, Canada,
Japan, Mexico, Paraguay, Romania, Uruguay;
Approved for: Environment: South Korea;
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, China, Czech Republic, European Union,
Malaysia, New Zealand, Philippines, Russia, South Korea, Switzerland,
Taiwan, Thailand;
Approved for: Feed: China, Colombia, Czech Republic, European Union,
Malaysia, Philippines, Russia, Switzerland, Taiwan, Thailand.
GE crop/Institution: Soybean/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: MON89788; Trait:
HT;
Commercialized in the United States[C]: No;
Commercial name[D]: Roundup Ready 2 Yield®;
Approved for: All uses: United States, Canada;
Approved for: Environment: Japan, Philippines, Taiwan;
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan, Philippines, Taiwan;
Approved for: Feed: Japan, Philippines, Taiwan.
GE crop/Institution: Squash/Asgrow (United States); Seminis Vegetable
Inc. (Canada);
Genetic transformation, or "event,"[A] and trait[B]: CZW-3; Trait: VR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada;
Approved for: Feed: [Empty].
GE crop/Institution: Squash/Upjohn (Seminis Vegetable Seeds);
Genetic transformation, or "event,"[A] and trait[B]: ZW20; Trait: VR;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada;
Approved for: Feed: [Empty].
GE crop/Institution: Sugarbeet/AgrEvo;
Genetic transformation, or "event,"[A] and trait[B]: T120-7; Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Japan;
Approved for: Feed: Japan.
GE crop/Institution: Sugarbeet/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: H7-1; Trait: HT;
Commercialized in the United States[C]: Yes;
Commercial name[D]: [D];
Approved for: All uses: United States, Canada;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, European Union, Mexico, New Zealand,
Philippines, Russia, Singapore, South Korea;
Approved for: Feed: European Union, Philippines, Singapore.
GE crop/Institution: Sugarbeet/Novartis Seeds; Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: GTSB77; Trait: HT;
Commercialized in the United States[C]: No;
Commercial name[D]: InVigor™;
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Australia, Japan, New Zealand, Philippines, Russia;
Approved for: Feed: Australia, Philippines.
GE crop/Institution: Tobacco;/Vector;
Genetic transformation, or "event,"[A] and trait[B]: Vector21-41;
Trait: NIC;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: [Empty];
Approved for: Environment: United States;
Approved for: Planting[E]: United States;
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/Agritope Inc.;
Genetic transformation, or "event,"[A] and trait[B]: 351N; Trait: DR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/Calgene;
Genetic transformation, or "event,"[A] and trait[B]: FLAVR SAVR[F];
Trait: DR;
Commercialized in the United States[C]: [C];
Commercial name[D]: FLAVR SAVR™;
Approved for: All uses: United States;
Approved for: Environment: Japan, Mexico;
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Japan, Mexico;
Approved for: Feed: Japan, Mexico.
GE crop/Institution: Tomato/Calgene;
Genetic transformation, or "event,"[A] and trait[B]: N73 1436-111;
Trait: DR;
Commercialized in the United States[C]: Last sold in 1997;
Commercial name[D]: FLAVR SAVR™;
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/DNA Plant Technology Corporation;
Genetic transformation, or "event,"[A] and trait[B]: 1345-4; Trait: DR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Mexico;
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: 5345; Trait: IR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada;
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/Monsanto;
Genetic transformation, or "event,"[A] and trait[B]: 8338; Trait: DR;
Commercialized in the United States[C]: No;
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: [Empty];
Approved for: Feed: [Empty].
GE crop/Institution: Tomato/Zeneca + Petoseed;
Genetic transformation, or "event,"[A] and trait[B]: B, Da, F; Trait:
DR;
Commercialized in the United States[C]: [C];
Commercial name[D]: [Empty];
Approved for: All uses: United States;
Approved for: Environment: [Empty];
Approved for: Planting[E]: [Empty];
Approved for: Food: Canada, Mexico;
Approved for: Feed: [Empty].
Source: GAO analysis of data from USDA, EPA, FDA, the Biotechnology
Industry Organization, the AGBIOS Company, and the International
Service for the Acquisition of Agri-Biotech Applications.
[A] Some events have a synonymous name; those event names are shown in
parentheses.
[B] HT (herbicide tolerance), IR (insect resistance), VR (virus
resistance), DR (delayed ripening/altered shelf life), OC (modified oil
content), LYS (enhanced lysine content), NIC (nicotine reduction), and
F (fertility restored).
[C] In some cases, we were not able to determine from the cited sources
whether the GE crop had been marketed.
[D] In some cases, we were not able to determine from the cited sources
whether the GE crop had a specific commercial name other than its event
name.
[E] Has been approved for planting/cultivation, but is not necessarily
in commercial production at the present time.
[F] Thirty-three lines of FLAVR SAVR™ tomato were granted nonregulated
status by USDA.
[End of table]
[End of section]
Appendix VII: Six Documented Incidents of Unauthorized Release of GE
Crops into the Food and Feed Supply:
As of August 2008, there were six documented incidents of the
unauthorized release of GE crops into the food or feed supply, or into
crops meant for the food or feed supply. Although federal agencies
determined that these incidents did not harm human or animal health,
they did cause financial losses in some cases, primarily from lost
sales to countries that would not accept food or feed containing any
amount of regulated GE varieties. The six incidents are discussed in
the following text.
StarLink Corn - 2000:
The first known unauthorized release of GE crops into the food supply
occurred in 2000 and involved a GE corn variety known by its trademark
name, StarLink. StarLink was engineered for insect resistance and
herbicide tolerance by Aventis CropScience. USDA deregulated StarLink
in 1998, and FDA accepted Aventis' data showing that, other than its
new pesticidal protein, StarLink was essentially the same as other
commercially available corn varieties. However, EPA granted only a
"split-registration" to the pesticidal protein in StarLink corn,
thereby allowing residue of the protein in animal feed but not allowing
it in the human food supply because of concerns that it may be an
allergen.[Footnote 27] In 2000, trace amounts of StarLink corn were
found in commercially available taco shells. According to USDA and
other sources, StarLink corn intended for animal feed, as well as corn
grown in adjacent fields that cross-pollinated with StarLink, likely
became commingled with corn approved for human consumption during
harvesting, transportation, and storage.
Federal agencies took a number of actions to divert Starlink corn from
the food supply. For example, APHIS began purchasing bushels of
StarLink corn at a 25-cent premium, with Aventis agreeing to reimburse
the agency for the costs. In addition, the food industry initiated
recalls of over 300 products that could have contained the regulated
protein. FDA also issued guidance for sampling and testing corn for the
presence of this protein. These actions dramatically reduced the amount
of the protein in the food supply. USDA testing done in 2006 and 2007
found no trace of the protein in the samples tested.
The StarLink incident had financial consequences, particularly in major
U.S. export markets. In 2001, USDA reported that corn sales to Japan--
the largest importer of U.S. corn--were down more than 20 percent from
the previous year, and exports to South Korea were down more than 70
percent, although USDA noted that some of this drop resulted from other
factors, such as larger-than-expected corn production and exports from
Argentina and Brazil. One study estimated that the StarLink incident
resulted in $26 million to $288 million in lost revenue for producers
in market year 2000/2001.[Footnote 28] (U.S. cash receipts for corn
totaled about $15.2 billion in 2000.) In addition, this study estimated
that the federal government bore indirect costs of $172 million to $776
million through USDA's Loan Deficiency Payments Program, which offers
producers short-term loans and direct payments if the price of a
commodity falls below the loan rate. During marketing year 2000/2001,
in which StarLink was first detected in the food supply, corn prices
fell below the loan rate, causing USDA to make additional income
support payments to producers. In a separate study that compared the
change in the price of corn with the change in the price of a
substitute good, sorghum, researchers estimated that the presence of
StarLink in the food supply caused a 6.8 percent drop in the price of
corn, lasting for 1 year.[Footnote 29] However, according to USDA,
declining corn prices may have been caused by other factors as well,
such as increases in supply due to favorable weather conditions or
reductions in demand.
Prodigene Corn - 2002:
Prodigene, a biotechnology company, was responsible for two incidents
in 2002 of the unauthorized release of GE corn designed to produce a
protein to be used in pig vaccine, according to USDA officials. In the
first incident, USDA ordered the company to destroy 155 acres of
conventional corn that might have been cross-pollinated by this GE
corn. In the second incident, USDA inspectors found a small number of
GE corn plants growing among conventional soybeans. USDA ordered
Prodigene to remove and destroy them; however, before the company did
so, the soybeans were harvested and sent to a grain elevator containing
500,000 bushels of soybeans. USDA detected the problem before the
soybeans were shipped from the elevator, and the agency ordered all of
the soybeans destroyed. Although none of this GE corn was found in the
food or feed supply, FDA issued a statement saying that the small
amount of regulated material present in the soybeans would have posed
no risk for human health.
Prodigene entered a consent decision with USDA in which Prodigene paid
a $250,000 fine and reimbursed USDA for the destruction of the 500,000
bushels of soybeans. The company also placed $1 million in a trust fund
to cover future mitigation efforts, implemented a new compliance
program, and agreed to third-party audits of its field trial
procedures. Despite these measures, Prodigene was involved in another
incident involving GE corn in 2004. During a field trial inspection,
USDA found evidence that additional GE corn may have been released to
the food or feed supply. The agency ordered corrective measures and
reached another settlement with Prodigene in 2007 that included a civil
penalty and an agreement that neither the company nor any of its
successors would apply for a GE notification or permit in the future to
conduct further field trials.
Bt10 Corn - 2004:
In 2004, Syngenta, a biotechnology developer, notified EPA that the
company inadvertently had distributed corn seed containing an
unregistered GE pesticide known as Bt10. Pesticides must be registered
with EPA before commercialization. Syngenta previously determined that
Bt10 was not suitable for commercialization and chose instead to
register with EPA a similar pesticidal product known as Bt11. However,
the company mislabeled some seed containers and, thus, inadvertently
bred and sold lines of Bt10 as Bt11. Syngenta estimated that the Bt10
variety may have been planted on as many as 37,000 acres of corn, or
about 1/10 of 1 percent of the annual corn acreage planted in the
United States from 2001 through 2004.
In response to this incident, federal agencies took several actions.
For example, although EPA determined that the protein in Bt10 was
identical to the one in Bt11 and had established a tolerance exemption
for Bt11, finding that there were no potential health hazards, it fined
Syngenta $1.5 million for the sale of an unregistered GE pesticide.
[Footnote 30] FDA also concluded that the presence of Bt10 corn in the
food and feed supply posed no food safety risks. In addition, USDA
fined Syngenta $375,000 for moving and planting a regulated GE plant
without the proper permit. In addition to the fines, Syngenta
identified and destroyed all affected plants and seeds as requested by
EPA and USDA, and the company developed additional quality control
mechanisms to help ensure its compliance with federal regulations.
The Bt10 incident disrupted U.S. corn exports. For example, the
European Union implemented emergency inspection measures for U.S. corn
from October 2005 to March 2007. In another case, South Korea required
that all imports of U.S. corn be tested and certified as being free of
Bt10. However, an agricultural trade group said U.S. corn exporters did
not suffer a significant loss of market share due to the Bt10 incident
because Syngenta paid for testing corn samples and diverting corn
associated with positive samples to approved markets.
Liberty Link Rice 601 and 604 - 2006:
In July 2006, another biotechnology developer, Bayer CropScience
(Bayer), informed USDA that it had detected regulated genetic material
in a variety of conventional long-grain rice known as Cheniere. USDA
launched an investigation in August that identified the regulated
material as LLRICE 601, a GE rice variety that Bayer engineered to
tolerate its Liberty Link brand of herbicide. USDA investigators
determined that LLRICE 601 and Cheniere had been grown at a research
facility affiliated with Louisiana State University between 1999 and
2001. However, they were unable to determine conclusively that the
commingling of GE and non-GE seeds, or cross-pollination took place at
this facility.
Meanwhile, in response to the LLRICE 601 incident, some state and
agricultural trade organizations instituted protocols for testing other
rice varieties for regulated genetic material. For example, in December
2006, the Arkansas State Plant Board notified USDA that another long-
grain rice variety, known as Clearfield 131 and marketed by the BASF
Company, had tested positive for regulated genetic material. USDA
investigators later determined that this genetic material came from
another, regulated GE rice variety, LLRICE 604, also engineered by
Bayer. As a result, USDA issued an emergency action notification to
halt the distribution and planting of Clearfield 131. LLRICE 604 and
Clearfield 131 also had been grown at the Louisiana State University
research facility. However, after a year-long investigation, USDA
concluded that there was insufficient information to make a conclusive
link or seek an enforcement action against either Bayer or this
research facility.
On November 24, 2006, USDA granted nonregulated status to LLRICE 601 on
the basis of its genetic similarity to another GE rice previously
approved for commercialization. However, LLRICE 604 remains regulated.
In addition, FDA published statements shortly after each incident
saying that the low-level presence in food or feed of the regulated
genetic material from these LLRICE varieties did not pose any human
health concerns. Nevertheless, despite these actions, the LLRICE
incidents affected the export market for U.S. long-grain rice, which in
recent years accounted for as much as 50 percent of total U.S. rice
sales. Specifically, several foreign countries either banned certain
varieties of U.S. rice or imposed new testing requirements on imports
from the United States. For example, Japan banned the importation of
U.S. long-grain rice. In another case, the European Union introduced
emergency measures for the testing of U.S. rice, resulting in numerous
shipments of U.S. rice being turned away from European ports. In
effect, this ended rice trade between the United States and the
European Union, which had accounted for as much as 10 percent of U.S.
long-grain rice exports in recent years.
Furthermore, citing market disruptions caused by the LLRICE incidents,
rice producers from five states filed a class action lawsuit against
Bayer. As of August 2008, the plaintiffs had not yet presented
estimates of rice producers' losses as a result of these incidents, but
an attorney representing the plaintiffs expects the demand for total
compensatory damages to be about $1 billion. These LLRICE incidents
also potentially cost the BASF Company millions of dollars in lost
sales of its Clearfield 131 rice. One environmental advocacy group
estimated in 2007 that the worldwide costs resulting from the LLRICE
incidents, including the costs associated with the loss of export
markets, seed testing, elevator cleaning, and food recalls in countries
where the variety of rice had not been approved, ranged from $741.0
million to $1.285 billion.[Footnote 31]
Event 32 Corn - 2006:
In February 2008, USDA, EPA, and FDA issued a joint public statement
announcing that Dow AgroScience (Dow), a biotechnology developer, had
discovered low levels of a regulated GE corn seed, called Event 32, in
three lines of commercially available GE corn seed sold under the brand
name Herculex. Dow engineered Event 32 to produce a pesticidal
substance. According to Dow, approximately 72,000 acres were planted
with corn seed containing low levels of Event 32 in 2006 and 2007.
Dow's investigation of this incident concluded that the mixing of Event
32 and Herculex seed probably occurred at a single research testing
field. As of August 2008, USDA's investigation was still ongoing.
Event 32 closely resembles another Dow GE corn variety, called Event
22, that is commercially available. Like Event 32, Dow engineered Event
22 to produce a pesticidal substance. Before commercialization, Event
22 was reviewed and granted nonregulated status by USDA, received a
pesticide registration from EPA, and completed a food safety
consultation with FDA. Given this history and the similarities between
Event 32 and Event 22, the three agencies, according to USDA, affirmed
that there were no public health risks posed by the low-level presence
of Event 32 in food and feed. In addition, USDA and EPA concluded there
were also no environmental risks. Nonetheless, USDA issued an
"emergency action notification" for Event 32 seed, and EPA issued a
stop-sale order. As of August 2008, these agencies were conducting
investigations to determine whether any violations had occurred.
According to Dow, it voluntarily recalled unplanted seed containing
Event 32. Dow also provided USDA with the testing method it used to
detect Event 32. However, USDA said this test may not be sensitive
enough to detect the low levels of Event 32 expected in the commercial
seed supply.
The Event 32 incident did not lead to detectable economic impacts. To
preclude trade disruptions, USDA provided relevant information to U.S.
trading partners, including information on the similarities between
Event 32 and Event 22, noting that the latter GE variety is accepted by
a number of countries, including Japan, the largest purchaser of U.S.
corn.
[End of section]
Appendix VIII: GE Regulatory Issues and Alternatives Discussed in
USDA's DEIS and Proposed Rule:
USDA's DEIS, announced in the Federal Register on July 17, 2007,
presents various issues and alternatives for regulating GE organisms,
including crops. Table 6 summarizes these issues and alternatives;
alternatives in bold type indicate USDA's preliminary preferred options
in the DEIS. USDA invited public comments on these issues and
alternatives by September 11, 2007. On October 9, 2008, after
considering the comments on the DEIS and other factors, USDA published
a proposed rule that, if adopted, would amend its regulations for GE
organisms, including plants. According to USDA, differences between the
proposed rule and the DEIS are primarily a matter of reorganizing and
realigning some materials and their corresponding regulatory
alternatives, using more descriptive terms in some criteria listed in
the alternatives, and choosing between regulatory alternatives that
fall within the analysis of the DEIS. The proposed rule contains a
table that provides a comparison between the proposed changes in the
rule and DEIS. Specifically, it indicates which of the DEIS
alternatives most closely match the proposed rule. We have included
that information in table 6.
Table 6: GE Regulatory Issues and Alternatives Discussed in USDA's DEIS
and Proposed Rule:
Issue: 1 - Broadening Regulatory Scope to Include GE Crops Posing
Noxious Weed Risk;
USDA is considering the broadening of its regulatory scope beyond GE
organisms that may pose a plant pest risk to include GE crops that may
pose a noxious weed risk and GE organisms that may be used to control
noxious weeds or plant pests (biological control agents).
Do regulatory requirements for these organisms need to be established?;
Alternatives considered (USDA's preliminary preference indicated):
1. No action--continue to regulate GE organisms as potential plant
pests, and use genetic transformation as the trigger for regulation
(event by event);
2. (USDA's preliminary preference) Expand the scope of what is
regulated by adding considerations of noxious weed risk and regulating
GE biological control organisms in addition to evaluating plant pest
risks, and use genetic transformation as the trigger for regulation.
Continue to regulate event by event;
3. Expand the scope of what is regulated by adding considerations of
noxious weed risk and regulating GE biological control organisms in
addition to evaluating plant pest risks. Use novelty of the trait in
the species as the trigger for regulation;
4. Exclude specific classes of highly familiar organisms and highly
domesticated, nonweedy crop plants and, potentially, those regulated by
another federal agency from regulation;
USDA's explanation: The second alternative would eliminate potential
gaps that may occur as genetic engineering techniques continue to
advance. The fourth alternative would allow USDA and a developer to
focus resources on GE crops that have a higher potential risk;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 2 or 3[A].
Issue: 2 - Use of Risk-Based Categories for New Products;
USDA is considering revisions to the regulations to increase
transparency and to address advances in technology that may create new
products and concerns;
Should a new system of risk-based categories be designed to deal with
new products and new concerns? If so, what criteria should be used to
establish the risk-based categories?
Alternatives considered:
1. No action--continue to use a two-tiered system (notifications and
permits);
2. Abolish categories and treat all future proposals for the
introduction of GE organisms on a case-by-case basis;
3. Establish a tiered permitting system for all organisms based on
newly devised criteria;
4. (USDA's preliminary preference) Establish a tiered permitting system
for plants based on newly devised criteria and evaluate permit
applications for introductions of nonplant organisms on a case-by-case
basis;
USDA's explanation: The fourth alternative would be more transparent,
allowing developers and the public to see that organisms are to be
regulated on the basis of risk and familiarity;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 4.
Issue: 3 - Regulatory Flexibility to Allow Commercialization Despite
Minor Unresolved Risks;
USDA is considering ways to provide regulatory flexibility for future
decisions by accommodating commercialization of certain GE organisms
while continuing, in some cases, to regulate the organisms on the basis
of minor unresolved risks. Other regulated articles could be treated as
they have been under the current system, in which all regulatory
restrictions are removed.
What environmental factors should be considered in distinguishing
between these kinds of decisions?
Alternatives considered:
1. No action--continue with current system granting full nonregulated
status to crops that removes them from all regulatory obligations;
2. (USDA's preliminary preference) Continue to allow for the option of
granting full nonregulated status and develop appropriate criteria and
procedures through which crops can be removed from permitting, but some
degree of agency oversight, as necessary, to mitigate any minor risks
is retained;
USDA's explanation: Under the second alternative, the added flexibility
of being able to retain some oversight may be useful for some types of
GE organisms that might be developed in the future;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 2.
Issue: 4 - Regulation of Crops Producing Pharmaceutical and Industrial
Compounds;
Are there changes that should be considered relative to environmental
review of, and permit conditions for, GE crops that produce
pharmaceutical and industrial compounds?
Alternatives considered:
1. No action--continue to allow food and feed crops to be used for the
production of pharmaceutical and industrial compounds and to allow
field testing under very stringent conditions;
2. (USDA's preliminary preference) Continue to allow food and feed
crops to be used for the production of pharmaceutical and industrial
compounds. The agency would impose confinement requirements, as
appropriate, based on the risk posed by the organism and would consider
food safety in setting conditions;
3. Do not allow crops producing substances not intended for food uses
to be field tested, that is, these crops could be grown only in
contained facilities;
4. Allow field testing only if the crop has no food or feed uses;
5. Allow field testing of food/feed crops producing substances not
intended for food uses only if food safety has been addressed;
USDA's explanation: Under the second alternative, the use of highly
stringent confinement measures can be used to protect the environment
from significant impact and the consideration of food safety will
further enhance human safety;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 2.
Issue: 5 - Regulation of Nonviable Plant Material;
The definition of noxious weeds in the Plant Protection Act includes
not only plants, but also plant products. On the basis of that
authority, USDA is considering the regulation of nonviable plant
material (i.e., plant materials, such as stems and leaves, that do not
propagate new plants);
Is the regulation of nonviable material appropriate and, if so, in
which cases should we regulate?
Alternatives considered:
1. No action--do not regulate nonviable GE material;
2. (USDA's preliminary preference) Regulate nonviable GE plant material
in certain circumstances, on the basis of the risks posed;
3. Regulate all nonviable GE plant material;
USDA's explanation: The second alternative is preferred because, in
most cases, nonviable plant material will not pose a risk. However, in
some cases, oversight might be required to ensure the safe handling and
disposal of this material;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 2.
Issue: 6 - New Mechanism for Regulating Nonfood/Nonfeed Crops Producing
Pharmaceutical and Industrial Compounds;
USDA is considering establishing a new mechanism involving USDA, the
states, and the producer for commercial production of plants not
intended for food or feed in cases where the producer would prefer to
develop and extract pharmaceutical and industrial compounds under
confinement conditions with governmental oversight, rather than USDA
granting nonregulated status to these plants.
What should be the characteristics of this mechanism?
Alternatives considered:
1. No action--continue to authorize field tests of crops not intended
for food or feed use under permit. Require application and review of
these permits on an annual basis;
2. (USDA's preliminary preference) Allow for special multiyear permits,
with ongoing oversight. The new system would maintain these crops under
regulation, but USDA oversight would be exercised in a different manner
than under the current system of permits;
USDA's explanation: Under the second alternative, the new system would
be just as protective of the environment as the current system, but in
a manner that is more efficient;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 1[B].
Issue: 7 - Allowance for Low-Level Presence of Regulated GE Material in
Crops, Food, Feed, or Seed;
The current regulations have no provision for the low-level presence of
regulated articles in commercial crops, food, feed, or seed of GE plant
material that has not completed the required regulatory processes;
Should low-level occurrences of a regulated article be exempted from
regulation?
Alternatives considered:
1. No action-- allow field testing to continue using current
confinement strategies to reduce the likelihood of regulated articles
occurring in commercial commodities or seeds;
2. Establish criteria under which occurrence of regulated articles
would be allowable, that is, considered not actionable by USDA. Do not
allow field testing of crops that do not meet all of these criteria,
including addressing food safety issues if applicable (i.e., if the GE
plant is a food crop);
3. (USDA's preliminary preference) Establish criteria under which
occurrence of regulated articles would be allowable, that is,
considered not-actionable by USDA. Allow field testing and impose
confinement strategies based on whether a plant meets the criteria;
4. Impose a very strict confinement regime on all field tests, as is
currently done for pharmaceutical and industrial crops, that would
further reduce the likelihood of regulated articles occurring in
commercial commodities or seeds;
USDA's explanation: The agency's analysis indicates that material
meeting the safety-based criteria of the third alternative would not
pose a risk for significant environmental impact;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 3.
Issue: 8 - Risk Assessment for Imported GE Commodities;
Should USDA provide expedited review or exemption from review for
certain low-risk, imported GE commodities intended for food, feed, or
processing that have received all necessary regulatory approvals in
their country-of-origin and are not intended for propagation in the
United States?
Alternatives considered:
1. No action--continue to evaluate commodity importation requests on a
case-by-case basis;
2. (USDA's preliminary preference) Establish criteria that will be
applied to determine the appropriate level of risk assessment for
imported GE commodities. This alternative could include a decision to
exempt certain organisms or to allow importation under conditions that
minimize environmental release;
3. Disallow importation of any commodity pending full USDA approval for
deregulation;
4. Accept any importation of a product from a foreign country that has
evaluated the safety of the product and approved it for unconfined
environmental release;
5. Accept any importation of a product from a foreign country that has
evaluated the safety of the product and approved it for unconfined
environmental release using a review process equivalent to USDA's;
USDA's explanation: Under the second alternative, the proposed
exemption criteria should ensure that exempted GE commodities would not
result in significant environmental impacts, even if an environmental
release should accidentally occur;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 1[C].
Issue: 9 - Interstate Movement of Well-Studied, Low-Risk GE Material;
Currently, GE Arabidopsis (a mustard plant commonly used in genetics
research) is exempt from interstate movement restrictions because they
are well-understood and extensively used in research;
Should the movement of GE Arabidopsis or other GE organisms be exempted
from movement restriction?
Alternatives considered:
1. No action--require interstate movement authorizations for all
organisms on the list in current regulations;
2. (USDA's preliminary preference) Exempt a class of GE crops or
organisms that are well-studied and present little or no environmental
risk from permit requirements for interstate movement as is currently
done for Arabidopsis;
3. Create a process to apply for an interstate movement exemption for a
particular species;
USDA's explanation: Regarding the second alternative, an expansion of
the exempted list to include other well-studied research organisms
would present little or no risk of significant environmental impact;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 3[D].
Issue: 10 - Container Requirements for Shipping GE Material;
What environmental considerations should be evaluated if USDA were to
move from prescriptive container requirements for shipment of GE
organisms to performance-based container requirements, supplemented
with guidance on ways to meet the performance standards?
Alternatives considered:
1. No action--retain current list of approved containers and issue
variances when necessary;
2. (USDA's preliminary preference) Switch to performance-based
standards for all transport containers;
3. Expand current list of approved containers and issue variances when
necessary;
USDA's explanation: Under the second alternative, having performance-
based standards would eliminate the need for variances, reduce the
burden on applicants, and increase the efficient use of agency
resources while protecting the environment;
Alternative(s) in DEIS that correspond to proposed change(s) to
regulations: 2.
Source: USDA's DEIS, "Introduction of Genetically Engineered
Organisms." The DEIS's availability for review was announced in the
Federal Register on July 17, 2007. (72 Fed. Reg. 39,021).
[A] According to the proposed rule, USDA would regulate GE plants
either on the basis that (1) the parent plant from which the GE plant
was derived is a plant pest or noxious weed, (2) the trait introduced
by genetic engineering could increase the potential of the GE plant to
be a plant pest or noxious weed, (3) the risk that the GE plant poses
as a plant pest or noxious weed is unknown, or (4) the Administrator of
APHIS determines that the GE plant poses a plant pest or noxious weed
risk. As such, aspects of both DEIS alternatives 2 and 3 are
incorporated into the proposed rule.
[B] According to the proposed rule, USDA concluded that the current
permitting procedures and the use of stringent permitting conditions
would effectively minimize the risk associated with the environmental
release of pharmaceutical or industrial compounds.
[C] USDA stated in the proposed rule that it is not proposing criteria
to evaluate risks of GE imported commodities that would allow it to
conduct expedited reviews, but it does not rule out the possibility of
developing such a system in the future.
[D] According to the proposed rule, USDA would retain existing
conditional exemptions from permitting requirements for the interstate
movement of certain GE organisms but is not proposing new exemptions.
Instead, the agency is proposing a petition process for approving
additional exemptions.
[End of table]
[End of section]
Appendix IX: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames (202) 512-3841 or Shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, James R. Jones, Jr.,
Assistant Director; Kevin S. Bray; Ross Campbell; Gloria Hernandez-
Saunders; Thomas J. McCabe; Alison D. O'Neill; Ilga Semeiks; and John
G. Smale, Jr., made key contributions to this report. Important
contributions were also made by Carol L. Kolarik and Peter E. Ruedel.
[End of section]
Related GAO Products:
Genetically Modified Foods: Experts View Regimen of Safety Tests as
Adequate, but FDA's Evaluation Process Could Be Enhanced. [hyperlink,
http://www.gao.gov/products/GAO-02-566]. Washington, D.C.: May 23,
2002.
International Trade: Concerns Over Biotechnology Challenge U.S.
Agricultural Exports. [hyperlink,
http://www.gao.gov/products/GAO-01-727]. Washington, D.C.: June 15,
2001.
Intellectual Property: Deposits of Biological Materials in Support of
Certain Patent Applications. [hyperlink,
http://www.gao.gov/products/GAO-01-49]. Washington, D.C.: October 16,
2000.
Biotechnology: Information on Prices of Genetically Modified Seeds in
the United States and Argentina. T-RCED/NSIAD-00-228. Washington, D.C.:
June 29, 2000.
Biotechnology: Information on Prices of Genetically Modified Seeds in
the United States and Argentina. RCED/NSIAD-00-55. Washington, D.C.:
January 21, 2000.
[End of section]
Footnotes:
[1] GAO, Results-Oriented Government: Practices That Can Help Sustain
Collaboration among Federal Agencies, [hyperlink,
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21,
2005).
[2] Not all field trials authorized under USDA permits or notifications
are carried out. A GE crop developer may decide not to plant the field
trial if, for example, the seeds have not performed as expected in
laboratory testing, the necessary quantity of seeds is not available,
or the weather is not favorable.
[3] As of July 10, 2008, USDA had not resolved 32 additional incidents.
IES is located within USDA's Animal and Plant Health Inspection
Service.
[4] A tolerance from EPA establishes the maximum amount of pesticidal
residue allowed on food or feed.
[5] The guidance does not apply to GE pesticides, which are regulated
by EPA. Nor does the guidance apply to plants used to produce
pharmaceutical compounds.
[6] See [hyperlink, http://www.gao.gov/products/GAO-06-15]. GAO also
identified an eighth practice--that is, reinforcing individual
accountability for collaborative efforts through performance management
systems--that we do not address in this report because it was beyond
the scope of our work.
[7] FDA has subjected only one substance added to a GE crop--a protein
added to a tomato engineered for delayed ripening--to its food additive
review process, and this was done at the request of the developer.
[8] The National Economic Council is a part of the White House's Office
of Policy Development. The council advises the President on matters
related to U.S. and global economic policy.
[9] Codex Alimentarius sets international food safety standards.
[10] The council has published three relevant reports at the request of
USDA: Ecological Monitoring of Genetically Modified Crops: A Workshop
Summary (2001); Environmental Effects of Transgenic Plants: The Scope
and Adequacy of Regulations (2002); and Biological Confinement of
Genetically Engineered Organisms (2004). The National Research Council
is part of the National Academy of Science--a private, nonprofit
organization comprising distinguished scientists and engineers with a
mandate from Congress requiring it to advise the federal government on
scientific and technical matters.
[11] Environmental Effects of Transgenic Plants.
[12] The council is a cabinet-level organization that includes
representatives from USDA, EPA, FDA, and other federal agencies.
[13] National Science and Technology Council, Agricultural
Biotechnology Risk Analysis Research in the Federal Government: Cross
Agency Cooperation (2006).
[14] Planting a "refuge" of crops that do not contain the pesticide Bt
near crops that do contain Bt is intended to reduce the likelihood that
insect populations will develop a resistance to Bt.
[15] Advisory Committee on Biotechnology and 21st Century Agriculture,
What Issues Should USDA Consider Regarding Coexistence among Diverse
Agricultural Systems in a Dynamic, Evolving, and Complex Marketplace?
(March 2008).
[16] GAO, Genetically Modified Foods: Experts View Regimen of Safety
Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced,
[hyperlink, http://www.gao.gov/products/GAO-02-566] (Washington, D.C.:
May 23, 2002).
[17] Under the Administrative Procedure Act, agencies generally provide
"interested persons" with an opportunity to comment on proposed rules,
and agencies generally respond to the issues and matters raised in
those comments in their final rules. The comments we analyzed are from
stakeholders who chose to submit comments to USDA; therefore, they are
not necessarily representative of all stakeholders who might have
insights or opinions regarding biotechnology regulation.
[18] The deadline for public comments on the proposed rule is November
24, 2008. After considering these comments, the agency plans to issue a
final rule accompanied by a Final Environmental Impact Statement.
However, the dates for these publications are uncertain.
[19] In its fiscal fear 2009 budget request, the administration is
requesting a 38 percent increase in funding--from $11.7 million to
$16.2 million--and a 28 percent increase in staffing--from 74 staff
years to 95 staff years--for USDA's Biotechnology Regulatory Services.
[20] Virus coat protein GE pesticides are derived from the genetic
material that plant viruses commonly use for protection.
[21] GAO, Results-Oriented Government: Practices That Can Help Sustain
Collaboration among Federal Agencies, [hyperlink,
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21,
2005).
[22] 51 Fed. Reg. 23,302 (June 26, 1986). The announcement followed
publication of a proposed coordinated framework in 1984. 49 Fed. Reg.
50,856 (Dec. 31, 1984).
[23] Because states have primary responsibility for pesticide use
within their borders, once a pesticide is registered with EPA, the
producer may also be required to register the pesticide with state
authorities. State registration may involve more stringent requirements
on how the pesticide is used.
[24] See 21 U.S.C. § 331. A food is deemed adulterated if, among other
things, it contains any added poisonous or deleterious substance that
may render the food injurious to health or if it contains an unapproved
food additive. See 21 U.S.C. § 342.
[25] FDA established its basic policy regarding the review of GE foods
in its 1992 Statement of Policy: Foods Derived from New Plant
Varieties. In 1997, FDA supplemented its 1992 policy with the current
Guidance on Consultation Procedures, clarifying procedures for the
initial and final consultations.
[26] According to FDA, 10 Investigational New Drug applications for
pharmaceutical products derived from GE crops have been submitted. As
of July 2008, only two of the applications were active, and neither
involved the use of food plants.
[27] In December 2000, an EPA science advisory panel concluded that the
pesticidal protein in StarLink had a medium probability of being a
potential allergen. However, the Centers for Disease Control and
Prevention, in a 2001 study of this protein's allergenicity conducted
for FDA, reported that "although the study participants may have
experienced allergic reactions, based upon the results of this study
alone, we cannot confirm that a reported illness was a food-associated
allergic reaction."
[28] T. Schmitz, A. Schmitz, and C. Moss, "The Economic Impact of
Starlink Corn," Agribusiness, vol. 21, no. 3 (2005).
[29] C. Carter and A. Smith, "Estimating the Market Effect of a Food
Scare: The Case of Genetically Modified StarLink Corn," Review of
Economics & Statistics, vol. 89, no. 3 (2007).
[30] The initial penalty exceeded $6 million, but Syngenta qualified
for a 75 percent reduction due to mitigating circumstances, including
its voluntary disclosure of the incident and cooperation with EPA
during the subsequent investigation.
[31] Neal E. Blue, Risky Business: Economic and Regulatory Impacts from
the Unintended Release of Genetically Engineered Rice Varieties into
the Rice Merchandising System of the U.S., Greenpeace International
(November 2007).
[End of section]
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